The following data is part of a premarket notification filed by Covidien with the FDA for Endo Clip Iii 5mm Clip Applier.
Device ID | K121194 |
510k Number | K121194 |
Device Name: | ENDO CLIP III 5MM CLIP APPLIER |
Classification | Clip, Implantable |
Applicant | COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
Contact | Angela Van Arsdale |
Correspondent | Angela Van Arsdale COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-19 |
Decision Date | 2012-05-03 |
Summary: | summary |