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FDA 510(k) Application Details - K971593
Device Classification Name
Bath, Hydro-Massage
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510(K) Number
K971593
Device Name
Bath, Hydro-Massage
Applicant
THE SILCRAFT CORP.
555 THIRTEENTH ST., N.W.
WASHINGTON, DC 20004-1109 US
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Contact
HOWARD M HOLSTEIN
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Regulation Number
890.5100
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Classification Product Code
ILJ
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More FDA Info for this Product Code
Date Received
05/01/1997
Decision Date
02/26/1998
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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