FDA 510(k) Application Details - K955243

Device Classification Name Mattress, Air Flotation, Alternating Pressure

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510(K) Number K955243
Device Name Mattress, Air Flotation, Alternating Pressure
Applicant KINETIC CONCEPTS, INC.
P.O. BOX 659508
SAN ANTONIO, TX 78216-9508 US
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Contact WILLIAM H QUIRK
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Regulation Number 880.5550

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Classification Product Code FNM
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Date Received 11/15/1995
Decision Date 10/23/1997
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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