FDA 510(k) Application Details - K013707

Device Classification Name Bath, Paraffin

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510(K) Number K013707
Device Name Bath, Paraffin
Applicant GLOBAL TV CONCEPTS, LTD.
676 SOUTH MILITARY TRAIL
DEERFIELD BEACH, FL 33442 US
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Contact LAURIE BRADEN
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Regulation Number 890.5110

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Classification Product Code IMC
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Date Received 11/08/2001
Decision Date 02/01/2002
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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