The following data is part of a premarket notification filed by Look, Inc. with the FDA for Polyviolene(tm) Suture.
| Device ID | K904054 |
| 510k Number | K904054 |
| Device Name: | POLYVIOLENE(TM) SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyester |
| 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 | GAS |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-10-03 |