The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Hem-o-lok Ligating Clip.
Device ID | K133202 |
510k Number | K133202 |
Device Name: | HEM-O-LOK LIGATING CLIP |
Classification | Clip, Implantable |
Applicant | TELEFLEX MEDICAL 2917 WECK DR. Research Triangle Park, NC 27709 |
Contact | Ashlea Ricci |
Correspondent | Ashlea Ricci TELEFLEX MEDICAL 2917 WECK DR. 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 | 2013-10-17 |
Decision Date | 2013-12-03 |
Summary: | summary |