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FDA 510(k) Application Details - K974070
Device Classification Name
Mattress, Air Flotation, Alternating Pressure
More FDA Info for this Device
510(K) Number
K974070
Device Name
Mattress, Air Flotation, Alternating Pressure
Applicant
PHYSIO DESIGNS, INC.
11 ARDEN LN.
COMMACK, NY 11725 US
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Contact
JAMES M TERRACCIANO
Other 510(k) Applications for this Contact
Regulation Number
880.5550
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Classification Product Code
FNM
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More FDA Info for this Product Code
Date Received
10/28/1997
Decision Date
01/06/1998
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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