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FDA 510(k), K123980, SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
FDA 510(k), K123980, SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
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510(K) Number: K123980
Device Name: SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
Manufacturer: RONALD MANNA
Device Classification Name: Wound Cleaner, Ultrasound
Regulation Number: NRB
Classification Product Code: 12/26/2012
Date Received: 03/05/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
Manufacturer: RONALD MANNA
Device Classification Name: Wound Cleaner, Ultrasound
Regulation Number: NRB
Classification Product Code: 12/26/2012
Date Received: 03/05/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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