FDA 510(k) Application Details - K041465

Device Classification Name Wheelchair, Mechanical

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510(K) Number K041465
Device Name Wheelchair, Mechanical
Applicant SINON CORPORATION
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY 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 06/02/2004
Decision Date 07/23/2004
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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