The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Surgical Sutures, Pgl, Gut, Deklene, Opthamend Etc.
| Device ID | K930738 |
| 510k Number | K930738 |
| Device Name: | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC |
| Classification | Suture, Absorbable, Natural |
| 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 | GAL |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAQ |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GAT |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-12 |
| Decision Date | 1994-07-26 |