The following data is part of a premarket notification filed by Unisurge, Inc. with the FDA for Uniclip Surgical Clip Applier.
Device ID | K926199 |
510k Number | K926199 |
Device Name: | UNICLIP SURGICAL CLIP APPLIER |
Classification | Applier, Surgical, Clip |
Applicant | UNISURGE, INC. 10231 BUBB RD. Cupertino, CA 95014 |
Contact | V, Johnson |
Correspondent | V, Johnson UNISURGE, INC. 10231 BUBB RD. Cupertino, CA 95014 |
Product Code | GDO |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-09 |
Decision Date | 1993-04-20 |