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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K024307
Device Name DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
Applicant
Sybaritic, Inc.
9220 James Ave. S.
Bloomington,  MN  55431
Applicant Contact RANDALL E BERGLUND
Correspondent
Sybaritic, Inc.
9220 James Ave. S.
Bloomington,  MN  55431
Correspondent Contact RANDALL E BERGLUND
Regulation Number890.5300
Classification Product Code
IMI  
Subsequent Product Code
ISA  
Date Received12/24/2002
Decision Date 07/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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