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510(k) K121487

LITECURE THERAPY COMPACT by Litecure, LLC — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2012
Date Received
May 18, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

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