MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES— 510(k) K112782
Substantially EquivalentMisonix, Inc.
FDA 510(k) clearance K112782 for MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES, Substantially Equivalent on 2011-12-01. Applicant: Misonix, Inc.. Device class: 2.
Clearance details
- Applicant
- Misonix, Inc.
- Product code
- Code NRB
- Device class
- Class 2
- Regulation
- 21 CFR 878.4410
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Farmingdale, NY, US
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More clearances from Misonix, Inc.
view allAdverse events under product code NRB
product code NRB- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.