The following data is part of a premarket notification filed by Look, Inc. with the FDA for Revised Labeling For Nylon Suture (polyamide).
Device ID | K926587 |
510k Number | K926587 |
Device Name: | REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) |
Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
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 | GAR |
CFR Regulation Number | 878.5020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-01 |
Decision Date | 1993-12-17 |