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 Endoscopic (& Open) Ta Surgical Stapler, Auto Suture Endoscopic (& Open) Gia Surgical Stapling Instrument.
Device ID | K032696 |
510k Number | K032696 |
Device Name: | AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT |
Classification | Staple, Implantable |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Chester Mccoy |
Correspondent | Chester Mccoy UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-02 |
Decision Date | 2003-12-01 |
Summary: | summary |