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510(k) K161920

Comfort Cover by Precision Dynamics Corporation — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2016
Date Received
July 13, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

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