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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K071607
Device Name ASA01 HEAVY DUTY SUCTION PUMP
Applicant
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
3 SHENGHUI SOUTH ROAD
NANTOU TOWN, ZHONGSHAN CITY
GUANGDONG,  CN
Applicant Contact POLO CHEN
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MORTER SIMON CHRISTENSEN
Regulation Number878.4780
Classification Product Code
BTA  
Date Received06/12/2007
Decision Date 06/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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