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510(k) K080465

WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES by Ws Far IR Medical Technology Co., Ltd. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2008
Date Received
February 21, 2008
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

Other clearances by Ws Far IR Medical Technology Co., Ltd.

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