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510(k) K113680

SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT by Soma Access Systems, LLC — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2011
Date Received
December 15, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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