The following data is part of a premarket notification filed by Look, Inc. with the FDA for Plain And Chromic Gut Suture.
Device ID | K903624 |
510k Number | K903624 |
Device Name: | PLAIN AND CHROMIC GUT SUTURE |
Classification | Suture, Absorbable, Natural |
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 | GAL |
CFR Regulation Number | 878.4830 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-08 |
Decision Date | 1990-09-18 |