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510(k) K052934

DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM by S.O.R. Internacional, S.A. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2006
Date Received
October 19, 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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