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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 K180115
Device Name TWBM Pump
Applicant
Taiwan Biomaterial Co., Ltd.
6F, No. 26-1, Sec.2, Shengyi Rd.
Zhubei,  TW 30261
Applicant Contact Monoj Mon Kalita
Correspondent
Taiwan Biomaterial Co., Ltd.
6F, No. 26-1, Sec.2, Shengyi Rd.
Zhubei,  TW 30261
Correspondent Contact Monoj Mon Kalita
Regulation Number878.4780
Classification Product Code
JCX  
Date Received01/16/2018
Decision Date 07/24/2018
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
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