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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 K181398
Device Name DV-300 Aspirator
Applicant
Ding Hwa Co., Ltd.
121 Sec 3 Zhongshan Rd.
Dacun,  TW 51542
Applicant Contact Eric Han
Correspondent
V2k Medical, Inc.
1221 Innsbruck Dr.
Sunnyvale,  CA  94089
Correspondent Contact John MacMahon
Regulation Number878.4780
Classification Product Code
JCX  
Date Received05/29/2018
Decision Date 07/23/2018
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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