FDA 510(k) Application Details - K041208

Device Classification Name Wheelchair, Powered

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510(K) Number K041208
Device Name Wheelchair, Powered
Applicant OTTO BOCK HEALTH CARE, LP
2 CARLSON PWY. STE. 100
MINNEAPOLIS, MN 55447-4467 US
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Contact BOB CLARKE
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 05/10/2004
Decision Date 10/01/2004
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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