The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Medicon Mogen Clamp.
| Device ID | K100916 |
| 510k Number | K100916 |
| Device Name: | MEDICON MOGEN CLAMP |
| Classification | Clamp, Circumcision |
| Applicant | MEDICON, E.G. GANSACKER 15 Tuttlingen, DE D-78532 |
| Contact | Joachim Schmid |
| Correspondent | Joachim Schmid MEDICON, E.G. GANSACKER 15 Tuttlingen, DE D-78532 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-02 |
| Decision Date | 2010-12-06 |
| Summary: | summary |