The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Surgimotor.
| Device ID | K954470 |
| 510k Number | K954470 |
| Device Name: | SURGIMOTOR |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton, DC 20005 -3306 |
| Contact | Robert P Reznick |
| Correspondent | Robert P Reznick W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W. SUITE 900 WEST Washignton, DC 20005 -3306 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-26 |
| Decision Date | 1995-12-08 |