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 |