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510(k) K131905

SOLID GEL PAD by Bluemtech — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2013
Date Received
June 26, 2013
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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