The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Misonix Inc. Fs-1000-rf Bipolar Forceps Accessory.
| Device ID | K052702 |
| 510k Number | K052702 |
| Device Name: | MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Contact | Ronald R Manna |
| Correspondent | Ronald R Manna MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2005-11-21 |
| Summary: | summary |