FDA 510(k) Application Details - K963674

Device Classification Name Mattress, Air Flotation, Alternating Pressure

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510(K) Number K963674
Device Name Mattress, Air Flotation, Alternating Pressure
Applicant LUMEX, INC.
100 SPENCE ST.
BAY SHORE, NY 11706-2290 US
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Contact JOSEPH ZANETTI
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Regulation Number 880.5550

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Classification Product Code FNM
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Date Received 09/13/1996
Decision Date 01/10/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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