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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 K132308
Device Name CLIQ DV-300 ASPIRATOR
Applicant
Ding Hwa Co., Ltd.
1083 Delaware Ave.
Buffalo,  NY  14209
Applicant Contact ROBERT O DEAN
Correspondent
Ding Hwa Co., Ltd.
1083 Delaware Ave.
Buffalo,  NY  14209
Correspondent Contact ROBERT O DEAN
Regulation Number878.4780
Classification Product Code
JCX  
Date Received07/25/2013
Decision Date 12/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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