The following data is part of a premarket notification filed by Look, Inc. with the FDA for Look Inc. 316l Stainless Steel Surgical Suture.
Device ID | K933686 |
510k Number | K933686 |
Device Name: | LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE |
Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
Applicant | LOOK, INC. 2020 LONNIE ABBOTT IND. BLVD. Ada, OK 74820 |
Contact | Mike Bollinger |
Correspondent | Mike Bollinger LOOK, INC. 2020 LONNIE ABBOTT IND. BLVD. Ada, OK 74820 |
Product Code | GAQ |
CFR Regulation Number | 878.4495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-29 |
Decision Date | 1993-12-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10848782046383 | K933686 | 000 |
10848782046017 | K933686 | 000 |
10848782046024 | K933686 | 000 |
10848782046031 | K933686 | 000 |
10848782046048 | K933686 | 000 |
10848782046055 | K933686 | 000 |
10848782046307 | K933686 | 000 |
10848782046314 | K933686 | 000 |
10848782046321 | K933686 | 000 |
10848782046338 | K933686 | 000 |
10848782046345 | K933686 | 000 |
10848782046352 | K933686 | 000 |
10848782046369 | K933686 | 000 |
10848782046376 | K933686 | 000 |
10848782046000 | K933686 | 000 |