FDA 510(k) Application Details - K082274

Device Classification Name Wheelchair, Mechanical

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510(K) Number K082274
Device Name Wheelchair, Mechanical
Applicant JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD.
14F-2, NO. 1, ZHUANGJING RD.
LANE 25
BANQIAO 220 TW
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Contact JUNNATA CHANG
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 08/11/2008
Decision Date 08/19/2008
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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