The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Ivs Tunneller.
Device ID | K010035 |
510k Number | K010035 |
Device Name: | IVS TUNNELLER |
Classification | Mesh, Surgical, Polymeric |
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 | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-01-04 |
Decision Date | 2001-04-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() IVS TUNNELLER 77321440 3453480 Dead/Cancelled |
Covidien AG 2007-11-05 |
![]() IVS TUNNELLER 76304799 not registered Dead/Abandoned |
Sherwood Services AG 2001-08-24 |