The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Deknatel(r) Microflex Ophthal Poly Suture,modified.
| Device ID | K911905 |
| 510k Number | K911905 |
| Device Name: | DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED |
| 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 | 1991-04-19 |
| Decision Date | 1991-07-02 |