The following data is part of a premarket notification filed by Stuart-lee, Inc. with the FDA for Stuart Lee Clip.
Device ID | K881741 |
510k Number | K881741 |
Device Name: | STUART LEE CLIP |
Classification | Clamp, Surgical, General & Plastic Surgery |
Applicant | STUART-LEE, INC. 41 TRUMBULL RD. Waterford, CT 06385 |
Contact | Vaughn Durham |
Correspondent | Vaughn Durham STUART-LEE, INC. 41 TRUMBULL RD. Waterford, CT 06385 |
Product Code | GDJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-22 |
Decision Date | 1988-06-03 |