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510(k) K142228

Heated Eye Pad by Digital Heat Corporation — Product Code IRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2015
Date Received
August 13, 2014
Clearance Type
Traditional
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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