The following data is part of a premarket notification filed by Look, Inc. with the FDA for Polypropylene Nonabsorbable Surgical Sutures.
Device ID | K903584 |
510k Number | K903584 |
Device Name: | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
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 | GAW |
CFR Regulation Number | 878.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-08 |
Decision Date | 1990-10-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10848782031846 | K903584 | 000 |
10848782031266 | K903584 | 000 |
10848782031273 | K903584 | 000 |
10848782031280 | K903584 | 000 |
10848782031297 | K903584 | 000 |
10848782031334 | K903584 | 000 |
10848782031341 | K903584 | 000 |
10848782031358 | K903584 | 000 |
10848782031365 | K903584 | 000 |
10848782031815 | K903584 | 000 |
10848782031822 | K903584 | 000 |
10848782031839 | K903584 | 000 |
10848782029492 | K903584 | 000 |