FDA 510(k) Application Details - K030427

Device Classification Name Wheelchair, Powered

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510(K) Number K030427
Device Name Wheelchair, Powered
Applicant IMC-HEARTWAY, LLC
6140 MID METRO DRIVE, SUITE 6
FORT MYERS, FL 33912 US
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Contact JUAN CARLOS RIVERA
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 02/10/2003
Decision Date 04/18/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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