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510(k) K052340

DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM by Alfa Tech Medical Systems, Ltd. — Product Code IMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2005
Date Received
August 26, 2005
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

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