FDA 510(k) Application Details - K091858

Device Classification Name Transport, Patient, Powered

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510(K) Number K091858
Device Name Transport, Patient, Powered
Applicant SUMMIT HARMAR, LLC
5905 FAWN LANE
CLEVELAND, OH 44144 US
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Contact EDWARD KROL
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Regulation Number 890.5150

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Classification Product Code ILK
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Date Received 06/23/2009
Decision Date 07/01/2009
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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