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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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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