Company ยท US
Contour Fabricators of Florida, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1996. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FRG | Wrap, Sterilization | 4 |
| BSY | Catheters, Suction, Tracheobronchial | 2 |
| DXT | Injector And Syringe, Angiographic | 2 |
| KYZ | Syringe, Irrigating (Non Dental) | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 1 |
| FMF | Syringe, Piston | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| KNY | Accessories, Catheter, G-U | 1 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | 1 |
| MJG | Device, Percutaneous, Biopsy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 4, 1996 | K955685 | RNS STERILE, DISPOSABLE CT BIOPSY TRAY Contour Fabricators of Florida, Inc. | DXT |
| Jun 25, 1996 | K962040 | RNS ARTHROGRAM TRAY Contour Fabricators of Florida, Inc. | FMI |
| Jun 3, 1996 | K955687 | RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY Contour Fabricators of Florida, Inc. | JAA |
| May 15, 1996 | K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY Contour Fabricators of Florida, Inc. | DWS |
| May 2, 1996 | K955684 | RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY Contour Fabricators of Florida, Inc. | DXT |
| Mar 12, 1996 | K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY Contour Fabricators of Florida, Inc. | HIO |
| Feb 21, 1996 | K955688 | RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY Contour Fabricators of Florida, Inc. | FRG |
| Feb 21, 1996 | K955686 | RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY Contour Fabricators of Florida, Inc. | FRG |
| Feb 21, 1996 | K955678 | RNS STERILE DISPOSABLE PUNCTURE TRAY Contour Fabricators of Florida, Inc. | FRG |
| Feb 1, 1996 | K955683 | RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY Contour Fabricators of Florida, Inc. | MJG |
| Aug 15, 1995 | K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION Contour Fabricators of Florida, Inc. | BSY |
| Aug 15, 1995 | K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION Contour Fabricators of Florida, Inc. | BSY |
| Aug 7, 1995 | K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER Contour Fabricators of Florida, Inc. | KYZ |
| Aug 7, 1995 | K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION Contour Fabricators of Florida, Inc. | KYZ |
| Jul 12, 1995 | K952925 | READY NURSE SYSTEM (RNS) TRACH CARE KIT Contour Fabricators of Florida, Inc. | LRQ |
| Sep 8, 1994 | K934072 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM Contour Fabricators of Florida, Inc. | KNY |
| Jun 10, 1994 | K935092 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM Contour Fabricators of Florida, Inc. | FMF |
| Dec 13, 1993 | K933151 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM Contour Fabricators of Florida, Inc. | FRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||