FDA 510(k) Application Details - K100824

Device Classification Name Wheelchair, Mechanical

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510(K) Number K100824
Device Name Wheelchair, Mechanical
Applicant SUZHOU KD MEDICAL
16F-2 (16A) NO. 462, SEC 2
CHONGDE RD BEITUN DIST
TAICHUNG 406 TW
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Contact JACOB CHANG
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 03/24/2010
Decision Date 05/25/2010
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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