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FDA 510(k) Application Details - K013707
Device Classification Name
Bath, Paraffin
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5110
More FDA Info for this Regulation Number
Classification Product Code
IMC
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More FDA Info for this Product Code
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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