The following data is part of a premarket notification filed by Look, Inc. with the FDA for Polyviolene Surgicl Suture.
Device ID | K943949 |
510k Number | K943949 |
Device Name: | POLYVIOLENE SURGICL SUTURE |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
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 | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-02 |
Decision Date | 1994-11-10 |