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FDA 510(k) Application Details - K982066
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K982066
Device Name
Wheelchair, Powered
Applicant
MERITS HEALTH PRODUCTS., INC.
P.O. BOX 150356
CAPE CORAL, FL 33915 US
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Contact
WINSTON ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
06/11/1998
Decision Date
08/31/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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