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510(k) K053041

MED SCULPT by General Project S.R.L. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2006
Date Received
October 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

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