FDA 510(k) Application Details - K050290

Device Classification Name Wheelchair, Mechanical

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510(K) Number K050290
Device Name Wheelchair, Mechanical
Applicant LERADO OVERSEA LTD. TWN BRANCH (BVI)
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY 30067 TW
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Contact JEN KE-MIN
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 02/07/2005
Decision Date 02/18/2005
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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