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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K140031
Device Name SUCTION PUMP
Applicant
DING HWA CO., LTD
1083 DELAWARE AVE.
BUFFALO,  NY  14223
Applicant Contact ROBERT O DEAN
Correspondent
DING HWA CO., LTD
1083 DELAWARE AVE.
BUFFALO,  NY  14223
Correspondent Contact ROBERT O DEAN
Regulation Number878.4780
Classification Product Code
JCX  
Date Received01/06/2014
Decision Date 04/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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