FDA 510(k) Application Details - K031618

Device Classification Name Wheelchair, Standup

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510(K) Number K031618
Device Name Wheelchair, Standup
Applicant COMFORT ORTHOPEDIC CO. LTD.
NO. 120 NAN SHIANG TSUEN,
SHOEI SHANG SHIANG
CHIA-YI TW
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Contact ERIC H.C. LEE
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Regulation Number 890.3900

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Classification Product Code IPL
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Date Received 05/23/2003
Decision Date 12/18/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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