The following data is part of a premarket notification filed by Circ Medtech with the FDA for Prepex System.
| Device ID | K103695 |
| 510k Number | K103695 |
| Device Name: | PREPEX SYSTEM |
| Classification | Clamp, Circumcision |
| Applicant | CIRC MEDTECH 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman CIRC MEDTECH 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-17 |
| Decision Date | 2012-01-10 |
| Summary: | summary |