The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Autosuture Endo Clip Iii 5 Mm Clip Applier.
Device ID | K071406 |
510k Number | K071406 |
Device Name: | AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER |
Classification | Clip, Implantable |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Jennifer Brennan |
Correspondent | Jennifer Brennan UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-21 |
Decision Date | 2007-11-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521047263 | K071406 | 000 |