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FDA 510(k) Application Details - K052008
Device Classification Name
Wheelchair, Powered
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510(K) Number
K052008
Device Name
Wheelchair, Powered
Applicant
IMC-HEARTWAY, LLC
6140 MID METRO DRIVE, SUITE 6
FORT MYERS, FL 33912 US
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Contact
JOHN FRYMARK
Other 510(k) Applications for this Contact
Regulation Number
890.3860
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Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
07/25/2005
Decision Date
09/16/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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