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FDA 510(k) Application Details - K102910
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K102910
Device Name
Wheelchair, Mechanical
Applicant
P.D.G., INC.
5905 FAWN LANE
CLEVELAND, OH 44141 US
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Contact
EDWARD A KROLL
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2010
Decision Date
12/23/2010
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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