FDA 510(k) Application Details - K090199

Device Classification Name Needle, Acupuncture, Single Use

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510(K) Number K090199
Device Name Needle, Acupuncture, Single Use
Applicant WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
QINGHONG RD., EHU TOWN
XISHAN DISTRICT
WUXI, JIANGSU 214116 CN
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Contact DORIS DONG
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Regulation Number 880.5580

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Classification Product Code MQX
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Date Received 01/27/2009
Decision Date 08/11/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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