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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 K182950
Device Name Acare Suction Unit
Applicant
Acare Technology Co., Ltd.
5f-4, No.24, Wuquan 2nd Rd, Xinzhuang Dist.
New Taipei City,  TW 242
Applicant Contact Kevin Tsai
Correspondent
RusCert Technology Co., Ltd.
8F.-2, No.21, Sec. 6, Zhongxiao E. Rd., Nangang Dist.
Taipei City,  TW 115
Correspondent Contact Ming-Yie Jan
Regulation Number878.4780
Classification Product Code
JCX  
Date Received10/23/2018
Decision Date 08/23/2019
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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