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510(k) K133981

AVACEN 100 by Avacen, Inc. — Product Code IRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2014
Date Received
December 26, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Heating, Powered
Device Class
Class II
Regulation Number
890.5740
Review Panel
PM
Submission Type

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