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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 K140809
Device Name CLIQ DV-300 ASPIRATOR
Applicant
Ding Hwa Co., Ltd.
11810 Wills Rd.
Alpharetta,  GA  30009
Applicant Contact JANNA BABSON
Correspondent
Ding Hwa Co., Ltd.
11810 Wills Rd.
Alpharetta,  GA  30009
Correspondent Contact JANNA BABSON
Regulation Number878.4780
Classification Product Code
JCX  
Date Received04/01/2014
Decision Date 06/23/2014
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
Predetermined Change
Control Plan Authorized		 No
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