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FDA 510(k) Application Details - K080385
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K080385
Device Name
Wheelchair, Powered
Applicant
E1 ENT., INC.
1290 S.W. 30TH AVE.
POMPANO BEACH, FL 33069 US
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Contact
JACK CHENG
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
02/13/2008
Decision Date
05/13/2008
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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