FDA 510(k) Application Details - K071607

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

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510(K) Number K071607
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
3 SHENGHUI SOUTH ROAD
NANTOU TOWN, ZHONGSHAN CITY
GUANGDONG CN
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Contact POLO CHEN
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 06/12/2007
Decision Date 06/26/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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