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510(k) K090008

TANDA RESTORE, MODEL PTSCS by Pharos Life Corporation — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2009
Date Received
January 2, 2009
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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