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FDA 510(k) Application Details - K970428
Device Classification Name
Mattress, Air Flotation, Alternating Pressure
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510(K) Number
K970428
Device Name
Mattress, Air Flotation, Alternating Pressure
Applicant
RESTXSYS
19636 CLUB HOUSE RD.
SUITE 120
GAITHERSBURG, MD 20879 US
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Contact
YOAV GERSHONI
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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
02/04/1997
Decision Date
05/14/1997
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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