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FDA 510(k) Application Details - K972115
Device Classification Name
Bed, Ac-Powered Adjustable Hospital
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510(K) Number
K972115
Device Name
Bed, Ac-Powered Adjustable Hospital
Applicant
VOLKER HEALTHCARE, INC.
55 NORTHERN BLVD, SUITE 410
GREAT NECK, NY 11021 US
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Contact
MILTON N BENEKE
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Regulation Number
880.5100
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Classification Product Code
FNL
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More FDA Info for this Product Code
Date Received
06/05/1997
Decision Date
08/29/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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