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510(k) K121311

THIXO-GEL ULTRASOUND SPRAY by Cloverline International Pharma Services GmbH — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2012
Date Received
May 1, 2012
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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