The following data is part of a premarket notification filed by Look, Inc. with the FDA for Look Temporary Intracanalicular Collagen Implant.
| Device ID | K897190 |
| 510k Number | K897190 |
| Device Name: | LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT |
| Classification | Plug, Punctum |
| Applicant | LOOK, INC. 2020 LONNIE ABBOTT IND. BLVD. Ada, OK 74820 |
| Contact | Gary Ainsworth |
| Correspondent | Gary Ainsworth LOOK, INC. 2020 LONNIE ABBOTT IND. BLVD. Ada, OK 74820 |
| Product Code | LZU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-28 |
| Decision Date | 1990-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851807007286 | K897190 | 000 |
| 00851807007279 | K897190 | 000 |
| 00851807007262 | K897190 | 000 |
| 10848782023797 | K897190 | 000 |
| 10848782023780 | K897190 | 000 |
| 10848782023773 | K897190 | 000 |
| 00848782023882 | K897190 | 000 |