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FDA 510(k) Application Details - K962585
Device Classification Name
Mattress, Air Flotation, Alternating Pressure
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510(K) Number
K962585
Device Name
Mattress, Air Flotation, Alternating Pressure
Applicant
UNITED MEDICAL EQUIPMENT, INC.
17 HENRY AVE.
PARK RIDGE, NJ 07656 US
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Contact
ARRON MEI
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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
07/01/1996
Decision Date
01/07/1997
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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