The following data is part of a premarket notification filed by Covidien, Formerly Us Surgical A Divison Of Tyco H with the FDA for Duet Trs Reloads, Duet Trs Reloads With Tri-staple Technology, Endo Gia Universal And Ultra Universal Staplers.
Device ID | K120258 |
510k Number | K120258 |
Device Name: | DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS |
Classification | Staple, Implantable |
Applicant | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
Contact | Jennifer Brennan |
Correspondent | Jennifer Brennan COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-27 |
Decision Date | 2012-02-29 |
Summary: | summary |