FDA 510(k) Application Details - K974296

Device Classification Name Bed, Ac-Powered Adjustable Hospital

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510(K) Number K974296
Device Name Bed, Ac-Powered Adjustable Hospital
Applicant INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA, OH 44036 US
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Contact EDWARD A KROLL
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Regulation Number 880.5100

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Classification Product Code FNL
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Date Received 11/17/1997
Decision Date 01/06/1998
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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