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FDA 510(k) Application Details - K052521
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K052521
Device Name
Wheelchair, Mechanical
Applicant
NISSIN MEDICAL INDUSTRIES CO., LTD
15637 FOX COVE CIRCLE
MOSELEY, VA 23120 US
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Contact
DARREN REEVES
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
09/14/2005
Decision Date
09/26/2005
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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