The following data is part of a premarket notification filed by Covidien Llc with the FDA for Lapro-clip Auto Suture Reusable Long Clip Applier.
Device ID | K143598 |
510k Number | K143598 |
Device Name: | Lapro-Clip Auto Suture Reusable Long Clip Applier |
Classification | Clip, Implantable |
Applicant | Covidien LLC 60 Middletown Ave North Haven, CT 06473 |
Contact | Rebecca Magnanimo |
Correspondent | Rebecca Magnanimo Covidien LLC 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 | 2014-12-18 |
Decision Date | 2015-03-12 |
Summary: | summary |