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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54026704625210 | K133202 | 000 |
| 44026704663857 | K133202 | 000 |
| 34026704922957 | K133202 | 000 |
| 44026704922961 | K133202 | 000 |
| 24026704725728 | K133202 | 000 |
| 34026704725701 | K133202 | 000 |
| 24026704725735 | K133202 | 000 |
| 24026704725711 | K133202 | 000 |
| 34026704725756 | K133202 | 000 |
| 24026704725742 | K133202 | 000 |
| 34026704725695 | K133202 | 000 |
| 44026704917080 | K133202 | 000 |
| 44026704917073 | K133202 | 000 |
| 34026704917069 | K133202 | 000 |
| 44026704917059 | K133202 | 000 |
| 34026704917045 | K133202 | 000 |
| 44026704663840 | K133202 | 000 |
| 44026704736568 | K133202 | 000 |
| 44026704736582 | K133202 | 000 |
| 54026704625203 | K133202 | 000 |
| 44026704625190 | K133202 | 000 |
| 44026704625183 | K133202 | 000 |
| 24026704601145 | K133202 | 000 |
| 24026704601138 | K133202 | 000 |
| 24026704601121 | K133202 | 000 |
| 24026704601114 | K133202 | 000 |
| 24026704601107 | K133202 | 000 |
| 24026704601091 | K133202 | 000 |
| 24026704601084 | K133202 | 000 |
| 24026704440539 | K133202 | 000 |
| 44026704695957 | K133202 | 000 |
| 44026704695933 | K133202 | 000 |
| 34026704695912 | K133202 | 000 |
| 34026704695905 | K133202 | 000 |
| 34026704917038 | K133202 | 000 |