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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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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