FDA 510(k) Application Details - K050264

Device Classification Name Wheelchair, Powered

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510(K) Number K050264
Device Name Wheelchair, Powered
Applicant STEALTH PRODUCTS
5905 FAWN LANE
CLEVELAND, OH 44141 US
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Contact EDWARD A KROLL
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 02/04/2005
Decision Date 02/11/2005
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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