NOVAFIL(TM)
FDA premarket approval P840041/S005 · decided 1994-04-20
Approval details
- PMA number
- P840041
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVAFIL(TM)
- Generic name
- Suture, nonabsorbable, synthetic, polyester
- Applicant
- Davis & Geck, Inc.
- Date received
- 1993-10-04
- Decision date
- 1994-04-20
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- GAS
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Danbury, CT
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SILK SUTURE (K982853) | Davis & Geck, Inc. | 1999-04-30 |
| SURGILON, DERMALON, & OPHTHALON (K981582) | Davis & Geck, Inc. | 1998-07-13 |
| ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL (K974015) | Davis & Geck, Inc. | 1998-05-18 |
| DEXON RAPID (DEXON R) (K980610) | Davis & Geck, Inc. | 1998-05-18 |
| MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE (K980062) | Davis & Geck, Inc. | 1998-03-20 |
| KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS (K973409) | Davis & Geck, Inc. | 1998-02-27 |
| ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO (K970857) | Davis & Geck, Inc. | 1997-11-05 |
| ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP (K972139) | Davis & Geck, Inc. | 1997-09-03 |