The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Misonix Sonicone(r) Ultrasonic Wound Care System And Accessories.
| Device ID | K112782 |
| 510k Number | K112782 |
| Device Name: | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES |
| Classification | Wound Cleaner, Ultrasound |
| 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 | NRB |
| CFR Regulation Number | 878.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-26 |
| Decision Date | 2011-12-01 |
| Summary: | summary |