The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Autosuture Absorbable Tack And Applicator.
Device ID | K071920 |
510k Number | K071920 |
Device Name: | AUTOSUTURE ABSORBABLE TACK AND APPLICATOR |
Classification | Staple, Implantable |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Daniel Campion |
Correspondent | Daniel Campion 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 | 2007-07-12 |
Decision Date | 2007-09-28 |
Summary: | summary |