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FDA 510(k) Application Details - K972176
Device Classification Name
Bed, Air Fluidized
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510(K) Number
K972176
Device Name
Bed, Air Fluidized
Applicant
KINETIC CONCEPTS, INC.
P.O. BOX 659508
SAN ANTONIO, TX 78265-9508 US
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Contact
WILLIAM H QUIRK
Other 510(k) Applications for this Contact
Regulation Number
890.5160
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Classification Product Code
INX
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More FDA Info for this Product Code
Date Received
06/09/1997
Decision Date
01/16/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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