Company ยท US
Roseburg SA
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1994. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 3 |
| HQZ | Frame, Spectacle | 3 |
| IOR | Wheelchair, Mechanical | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 |
| FXX | Mask, Surgical | 1 |
| FYA | Gown, Surgical | 1 |
| FYF | Cap, Surgical | 1 |
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | 1 |
| HHI | System, Abortion, Vacuum | 1 |
| HKW | Prism, Bar, Ophthalmic | 1 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 1 |
| HRX | Arthroscope | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| ITI | Wheelchair, Powered | 1 |
| JDN | Implant, Fixation Device, Spinal | 1 |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 1 |
| KGO | Surgeon'S Gloves | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 1994 | K931155 | STAPLE, FIXATION BONE; SCREW FIXATION BONE Roseburg SA | HWC |
| Mar 9, 1989 | K890081 | CALIUS-ISABEL CANOVAS SUNGLASSES Roseburg SA | HQY |
| Jan 24, 1989 | K885275 | ASSENAT-BLESCHET SUNGLASSES Roseburg SA | HQY |
| Aug 26, 1988 | K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES Roseburg SA | KGO |
| Dec 7, 1987 | K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY Roseburg SA | JDN |
| Nov 17, 1987 | K874317 | POIRIER KID-ROLLER MANUAL WHEELCHAIR Roseburg SA | IOR |
| Jul 21, 1987 | K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY Roseburg SA | GBI |
| May 29, 1987 | K871689 | SPECTACLE FRAME - LORRAINE Roseburg SA | HQZ |
| May 29, 1987 | K871688 | SPECTACLE FRAME - DANIELLE Roseburg SA | HQZ |
| May 14, 1987 | K870654 | EFER ARTHROSCOPE Roseburg SA | HRX |
| Mar 16, 1987 | K864436 | STAVIP 3000 Roseburg SA | JJN |
| Feb 4, 1987 | K864791 | POIRIER POWERED WHEELCHAIR Roseburg SA | ITI |
| Dec 17, 1986 | K864790 | POIRIER MANUAL WHEELCHAIR Roseburg SA | IOR |
| Oct 24, 1986 | K860953 | SUNGLASSES (NON-PRESCRIPTION) Roseburg SA | HQY |
| Mar 31, 1986 | K860955 | SPECTACLES LENS Roseburg SA | HQG |
| Mar 31, 1986 | K860954 | SPECTACLES FRAME Roseburg SA | HQZ |
| Dec 13, 1985 | K851560 | PORTASPIR II Roseburg SA | BTA |
| Jun 4, 1985 | K850294 | CANAL FINDER Roseburg SA | EGS |
| May 23, 1985 | K851555 | OPTHALMIC BAR PRISM Roseburg SA | HKW |
| Apr 30, 1985 | K851559 | TURQUOISE Roseburg SA | FYA |
| Apr 30, 1985 | K851558 | SURGICAL CAP CALOT Roseburg SA | FYF |
| Apr 30, 1985 | K851556 | OP-FACE MASK(MASQUE DE CHIRUGIE) Roseburg SA | FXX |
| Apr 30, 1985 | K851554 | OVERSHOES (SURCHAUSSURES Roseburg SA | FXP |
| Feb 28, 1985 | K850312 | GYNASPYR VACUUM CURETTAGE UNIT Roseburg SA | HHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||