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510(k) K120217

SONICSTIMU COMBO THERAPEUTIC DEVICE by Shenzhen Dongdixin Technology Co., Ltd. — Product Code IMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2012
Date Received
January 24, 2012
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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