FDA 510(k) Application Details - K974319

Device Classification Name Mattress, Air Flotation, Alternating Pressure

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510(K) Number K974319
Device Name Mattress, Air Flotation, Alternating Pressure
Applicant WHEELCHAIRS OF KANSAS
P.O. BOX 320
204 W. 2ND ST.
ELLIS, KS 67637 US
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Contact LEE FRICKEY
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Regulation Number 880.5550

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Classification Product Code FNM
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Date Received 11/17/1997
Decision Date 01/22/1998
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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