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510(k) K070400

LC THERAPY, MODEL LCT-1000 by Litecure, LLC — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2007
Date Received
February 12, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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