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510(k) K063728

TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM by Alfa Tech Medical Systems, Ltd. — Product Code IMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2007
Date Received
December 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type

Other clearances by Alfa Tech Medical Systems, Ltd.

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