FDA 510(k) Application Details - K161241

Device Classification Name Wheelchair, Powered

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510(K) Number K161241
Device Name Wheelchair, Powered
Applicant Alber GmbH
Vor dem Weissen Stein 21
Albstadt 72461 DE
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Contact MICHAEL VENT
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 05/02/2016
Decision Date 10/05/2016
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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