OXYCELL
FDA premarket approval N5798/S007 · decided 1995-07-24
Approval details
- PMA number
- N5798
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OXYCELL
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date received
- 1995-02-16
- Decision date
- 1995-07-24
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin Lake, NJ
- Statement
- APPROVAL FOR A CHANGE IN THE QUALITY CONTROL PROCEDURES FOR POST-STERILIZATION LOTS OF OXYCEL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BACTEC MGIT 960 SIR KITS (K003062) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-06-06 |
| 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (K003553) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-03-21 |
| BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (K003461) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-02-01 |
| B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (K002938) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-11-29 |
| BD DIRECTIGEN FLU A+B (K001364) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-06-28 |
| MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (K000762) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-04-25 |
| GATIFLOXACIN, 5 UG, BBL SENSI-DISC (K000829) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-04-13 |
| SYNERCID, 15 UG, BBL SENSI-DISC (K993186) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999-11-03 |