The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Meisinger Benex, Model Be001.
| Device ID | K062130 |
| 510k Number | K062130 |
| Device Name: | MEISINGER BENEX, MODEL BE001 |
| Classification | Forceps, Tooth Extractor, Surgical |
| Applicant | HAGER & MEISINGER GMBH 7442 S. TUCSON WAY SUITE 130 Centennial, CO 80112 |
| Contact | Alex Miller |
| Correspondent | Alex Miller HAGER & MEISINGER GMBH 7442 S. TUCSON WAY SUITE 130 Centennial, CO 80112 |
| Product Code | EMG |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-26 |
| Decision Date | 2007-04-16 |