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510(k) K113668

HEALITE II SYSTEM by Lutronic Corporation — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2012
Date Received
December 13, 2011
Clearance Type
Traditional
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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