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FDA 510(k) Application Details - K992702
Device Classification Name
Cover, Mattress (Medical Purposes)
More FDA Info for this Device
510(K) Number
K992702
Device Name
Cover, Mattress (Medical Purposes)
Applicant
ALLERGY DIRECT
8800 EAST 63RD ST.
KANSAS CITY, MO 64133 US
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Contact
GAVIN MCLACLAN
Other 510(k) Applications for this Contact
Regulation Number
880.6190
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Classification Product Code
FMW
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More FDA Info for this Product Code
Date Received
08/12/1999
Decision Date
11/08/1999
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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