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510(k) K151070

Sonishield 100 Antimicrobial Ultrasound Gel by Quotient Medical — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2016
Date Received
April 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Coupling, Ultrasound
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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