The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Modified Suture Disp. Endoscopic Surgical Clip App.
Device ID | K890941 |
510k Number | K890941 |
Device Name: | MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP |
Classification | Applier, Surgical, Clip |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Curtis Raymond |
Correspondent | Curtis Raymond UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | GDO |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-23 |
Decision Date | 1989-04-07 |