FDA 510(k) Application Details - K052934

Device Classification Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat

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510(K) Number K052934
Device Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant S.O.R. INTERNACIONAL, S.A.
2454 MCMULLEN BOOTH ROAD
SUITE 427, CLEARWATER, FL 33759 US
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Contact IAN GORDON
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Regulation Number 890.5300

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Classification Product Code IMI
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Date Received 10/19/2005
Decision Date 06/12/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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