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FDA 510(k) Application Details - K052934
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
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
More FDA Info for this Regulation Number
Classification Product Code
IMI
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More FDA Info for this Product Code
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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