BIO-SORB ABSORBABLE DUSTING POWDER
FDA premarket approval N6264/S003 · decided 1985-09-10
Approval details
- PMA number
- N6264
- Supplement
- S003
- Trade name
- BIO-SORB ABSORBABLE DUSTING POWDER
- Generic name
- Powder, dusting, surgical
- Applicant
- Johnson & Johnson Medical, Inc.
- Date received
- 1985-08-21
- Decision date
- 1985-09-10
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- KGP
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- New Brunswick, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (K001690) | Johnson & Johnson Medical, Inc. | 2000-07-31 |
| ADVANCED NIBP MODULE (K982641) | Johnson & Johnson Medical, Inc. | 1999-03-29 |
| NU-GEL * WOUND DRESSING (K983362) | Johnson & Johnson Medical, Inc. | 1998-12-16 |
| FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (K982597) | Johnson & Johnson Medical, Inc. | 1998-08-20 |
| CRITIKON SOFT BLOOD PRESSURE CUFF (K974080) | Johnson & Johnson Medical, Inc. | 1998-05-18 |
| I.V. CATHETER SYSTEM (K980493) | Johnson & Johnson Medical, Inc. | 1998-04-28 |
| OBSERVER * CENTRAL STATION (K972498) | Johnson & Johnson Medical, Inc. | 1998-02-17 |
| ULTRALON POWDER FREE LATEX SURGICAL GLOVE (K973699) | Johnson & Johnson Medical, Inc. | 1997-12-16 |