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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 K130001
Device Name CARE SU01A SUCTION ASPIRATOR
Applicant
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
THE 2F AND 3F, G BUILDING, NO.1 HUABAO
ROAD SOUTHERN
FOSHAN, GUANGDONG,  CN 528000
Applicant Contact GANG WU
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number878.4780
Classification Product Code
JCX  
Date Received01/02/2013
Decision Date 07/25/2013
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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