Company ยท US
Custom Pack Reliability
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 1996. Name variants (Inc, Corp, punctuation) are merged.
21510(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 | 7 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 |
| JOL | Catheter And Tip, Suction | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 |
| LWI | Ultrasound, Sinus | 1 |
| MLS | Labor And Delivery Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 1996 | K960205 | CPR TRACHEOTOMY CARE TRAY Custom Pack Reliability | BTO |
| May 23, 1996 | K960243 | CPR C-SECTION DELIVERY PACK Custom Pack Reliability | MLS |
| May 23, 1996 | K960239 | CPR D & C TRAY Custom Pack Reliability | HHK |
| Apr 15, 1996 | K960216 | CPR SUCTION CATHETER KIT Custom Pack Reliability | JOL |
| Apr 12, 1996 | K960213 | CPR TOTAL HIP PACK Custom Pack Reliability | FRG |
| Apr 12, 1996 | K960211 | CPR TOTAL KNEE PACK Custom Pack Reliability | FRG |
| Apr 12, 1996 | K960210 | CPR ORTHO HAND PACK Custom Pack Reliability | FRG |
| Apr 12, 1996 | K960206 | CPR DRESSING CHANGE TRAY Custom Pack Reliability | FRG |
| Apr 4, 1996 | K960209 | CPR HEART PACK Custom Pack Reliability | GAW |
| Apr 1, 1996 | K960215 | CPR URETHRAL CATHETER TRAY Custom Pack Reliability | FCM |
| Apr 1, 1996 | K960214 | CPR FOLEY CAHTETER KIT Custom Pack Reliability | FCM |
| Apr 1, 1996 | K960212 | CPR IRRIGATION TRAY Custom Pack Reliability | KYZ |
| Mar 28, 1996 | K960238 | CPR SUTURE REMOVAL KIT Custom Pack Reliability | FRG |
| Mar 28, 1996 | K960236 | CPR LAP SPONGES Custom Pack Reliability | GDY |
| Mar 28, 1996 | K960223 | CPR YANKAUER Custom Pack Reliability | GCX |
| Mar 28, 1996 | K960218 | CONNECTING TUBING Custom Pack Reliability | BYY |
| Mar 28, 1996 | K960217 | CPR URINE BAG Custom Pack Reliability | FAQ |
| Mar 28, 1996 | K960208 | CPR BASIC SET-UP TRAY Custom Pack Reliability | FRG |
| Mar 22, 1996 | K960241 | CPR GENERAL SURGERY TRAY Custom Pack Reliability | LWI |
| Mar 12, 1996 | K960242 | CPR EYE TRAY Custom Pack Reliability | KKX |
| Feb 27, 1996 | K960207 | CPR LACERATION TRAY Custom Pack Reliability | FRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||