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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
Other 510(k) Applications for this Contact
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
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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