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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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More FDA Info for this Product Code
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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