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FDA 510(k) Application Details - K990139
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K990139
Device Name
Wheelchair, Mechanical
Applicant
KENDA USA
7095 AMERICANA PKWY.
PO BOX 0132
REYNOLDSBURG, OH 43068-4118 US
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Contact
LONNIE WELLS
Other 510(k) Applications for this Contact
Regulation Number
890.3850
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Classification Product Code
IOR
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More FDA Info for this Product Code
Date Received
01/19/1999
Decision Date
04/29/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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