The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Deknatel Microflex Ophthalmic Polypropylene Suture.
| Device ID | K903643 |
| 510k Number | K903643 |
| Device Name: | DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Harry Savard |
| Correspondent | Harry Savard DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-10 |
| Decision Date | 1990-12-24 |