FDA 510(k) Application Details - K950025

Device Classification Name Wheelchair, Powered

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510(K) Number K950025
Device Name Wheelchair, Powered
Applicant DATATRAN, INC.
246 DODGE AVE.
EASR HAVEN, CT 06512 US
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Contact SAL ALBRACCIO
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 01/04/1995
Decision Date 09/03/1996
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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