DEKLENE(TM)
FDA premarket approval P810028/S008 · decided 1989-01-31
Approval details
- PMA number
- P810028
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DEKLENE(TM)
- Generic name
- Suture, nonabsorbable, synthetic, polyethylene
- Applicant
- Deknatel, Inc.
- Date received
- 1987-12-30
- Decision date
- 1989-01-31
- Days to decision
- 398 days
- Decision code
- APPR
- Product code
- GAT
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Fall River, MA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K963850) | Deknatel, Inc. | 1997-04-22 |
| SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR (K962683) | Deknatel, Inc. | 1997-01-10 |
| DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG (K964070) | Deknatel, Inc. | 1996-12-31 |
| PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) (K963098) | Deknatel, Inc. | 1996-11-08 |
| PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR (K962856) | Deknatel, Inc. | 1996-08-28 |
| DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER (K925243) | Deknatel, Inc. | 1994-07-27 |
| SUTURES POLYPROP., POLYETHELINE, NYLON & SILK (K930739) | Deknatel, Inc. | 1994-07-26 |
| SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC (K930738) | Deknatel, Inc. | 1994-07-26 |