The following data is part of a premarket notification filed by Oculo Plastik, Inc. with the FDA for Eptfe Sheet Covering For Ocular Implant.
| Device ID | K934834 |
| 510k Number | K934834 |
| Device Name: | EPTFE SHEET COVERING FOR OCULAR IMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | OCULO PLASTIK, INC. 1170 EAST HENRI-BOURASSA BLVD. Montreal, Quebec Canada, CA H2c 1g4 |
| Contact | Jean F Durette |
| Correspondent | Jean F Durette OCULO PLASTIK, INC. 1170 EAST HENRI-BOURASSA BLVD. Montreal, Quebec Canada, CA H2c 1g4 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-08 |
| Decision Date | 1994-05-05 |