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510(k) K120156

PUREIMAGE ULTRASOUND TRANSMISSION GEL by Medline — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2012
Date Received
January 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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