The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting Clips.
Device ID | K132658 |
510k Number | K132658 |
Device Name: | HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS |
Classification | Clip, Implantable |
Applicant | TELEFLEX MEDICAL 2917 WECK DR. Research Triangle Park, NC 27709 |
Contact | Ashlea Ricci, Rac |
Correspondent | Ashlea Ricci, Rac 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 | 2013-08-26 |
Decision Date | 2013-11-27 |
Summary: | summary |