The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Weck Auto Endo5 Hem-o-lok Ligating Clip Applier.
| Device ID | K152081 |
| 510k Number | K152081 |
| Device Name: | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier |
| Classification | Clip, Implantable |
| Applicant | Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Ashlea Ricci |
| Correspondent | Ashlea Ricci Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2015-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704553123 | K152081 | 000 |