FDA 510(k) Application Details - K052548

Device Classification Name Wheelchair, Mechanical

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510(K) Number K052548
Device Name Wheelchair, Mechanical
Applicant AMG MEDICAL INC.
8505 DALTON
MONTREAL, QUEBEC H4T 1V5 CA
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Contact KENNETH LEVESQUE
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 09/16/2005
Decision Date 01/06/2006
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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