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FDA 510(k) Application Details - K061475
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K061475
Device Name
Wheelchair, Mechanical
Applicant
PDG PRODUCT DESIGN GROUP, INC.
UNIT 102-366 E. KENT AVE.
SOUTH
VANCOUVER, BC V5X 4N6 CA
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Contact
NANCY BALCOM
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
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More FDA Info for this Product Code
Date Received
05/30/2006
Decision Date
06/14/2006
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
Y
Expedited Review
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