FDA 510(k) Application Details - K082246

Device Classification Name Wheelchair, Mechanical

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510(K) Number K082246
Device Name Wheelchair, Mechanical
Applicant DIGNITY MEDICAL DEVICES, INC
16917 73RD PLACE N
MAPLE GROVE, MN 55311 US
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Contact CHARMAINE SUTTON
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 08/08/2008
Decision Date 09/09/2008
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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