The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Sutures Polyprop., Polyetheline, Nylon & Silk.
| Device ID | K930739 |
| 510k Number | K930739 |
| Device Name: | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Harry C Savard |
| Correspondent | Harry C Savard DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Product Code | GAP |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GAT |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-12 |
| Decision Date | 1994-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704590104 | K930739 | 000 |