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FDA 510(k) Application Details - K980033
Device Classification Name
Bath, Hydro-Massage
More FDA Info for this Device
510(K) Number
K980033
Device Name
Bath, Hydro-Massage
Applicant
FERNO-WASHINGTON, INC.
70 WEIL WAY
WILMINGTON, OH 45177 US
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Contact
ERIC N BESANKO
Other 510(k) Applications for this Contact
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
01/05/1998
Decision Date
04/21/1998
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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