The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Weck Hem-o-lok Auto Endo5 Ligating Clip Applier.
Device ID | K142777 |
510k Number | K142777 |
Device Name: | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier |
Classification | Clip, Implantable |
Applicant | Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
Contact | Ashlea Ricci |
Correspondent | Ashlea Ricci Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-26 |
Decision Date | 2014-12-19 |
Summary: | summary |