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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 K190105
Device Name ZOOM Aspiration Pump
Applicant
Taiwan Biomaterial Co., Ltd.
6f, # 26-1, Sec.2, Shengyi Rd.
Zhubei,  TW 30261
Applicant Contact Monoj Mon Kalita
Correspondent
Taiwan Biomaterial Co., Ltd.
6f, # 26-1, Sec.2, Shengyi Rd.
Zhubei,  TW 30261
Correspondent Contact Monoj Mon Kalita
Regulation Number878.4780
Classification Product Code
JCX  
Date Received01/22/2019
Decision Date 02/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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