The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Hem-o-lok Ligation Clip.
Device ID | K062914 |
510k Number | K062914 |
Device Name: | HEM-O-LOK LIGATION CLIP |
Classification | Clip, Implantable |
Applicant | TELEFLEX MEDICAL 2345 WAUKEGAN ROAD Bannockburn, IL 60015 |
Contact | Lori Hays |
Correspondent | Lori Hays TELEFLEX MEDICAL 2345 WAUKEGAN ROAD Bannockburn, IL 60015 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-27 |
Decision Date | 2006-11-02 |
Summary: | summary |