The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture* Ilm** Kit.
Device ID | K971201 |
510k Number | K971201 |
Device Name: | AUTO SUTURE* ILM** KIT |
Classification | Clip, Implantable |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Victor Clavelli |
Correspondent | Victor Clavelli 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 | 1997-04-01 |
Decision Date | 1997-06-03 |
Summary: | summary |