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 Premium Plus Ceea Disposable Stapler.
Device ID | K024275 |
510k Number | K024275 |
Device Name: | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER |
Classification | Staple, Implantable |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Sarah Hubeny |
Correspondent | Sarah Hubeny 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 | 2002-12-23 |
Decision Date | 2003-03-14 |
Summary: | summary |