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FDA 510(k) Application Details - K980920
Device Classification Name
Bath, Hydro-Massage
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510(K) Number
K980920
Device Name
Bath, Hydro-Massage
Applicant
BOUVIER HYDRO, INC.
100 WALNUT ST. SUITE 20
P.O. BOX 2874
CHAMPLAIN,, NY 12919 US
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Contact
ALAIN JOUAN
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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
03/10/1998
Decision Date
07/16/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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