The following data is part of a premarket notification filed by Oculo Plastik, Inc. with the FDA for New Iowa Motility Implant.
| Device ID | K900080 |
| 510k Number | K900080 |
| Device Name: | NEW IOWA MOTILITY IMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | OCULO PLASTIK, INC. 1170 EAST HENRI-BOURASSA BLVD. Montreal, Quebec Canada, CA H2c 1g4 |
| Contact | Jean-francois Durett |
| Correspondent | Jean-francois Durett 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 | 1990-01-04 |
| Decision Date | 1990-03-23 |