The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Modified Auto Suture*vcs** Anastomotic**clip Cartridge.
Device ID | K984438 |
510k Number | K984438 |
Device Name: | MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE |
Classification | Clip, Implantable |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Christopher A Graham |
Correspondent | Christopher A Graham UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-14 |
Decision Date | 1999-01-07 |
Summary: | summary |