FDA 510(k) Application Details - K151717

Device Classification Name Wheelchair, Powered

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510(K) Number K151717
Device Name Wheelchair, Powered
Applicant Alber GmbH
Vor dem Weissen Stein 21
Albstadt D72461 DE
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Contact Bernd Engels
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 06/25/2015
Decision Date 02/23/2016
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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