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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K150253
Device Name Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
Applicant
Taiwan Surgical Corporation
3f., # 12. Sec 2, Shengyi Rd.
Zhubei City,  TW 30261
Applicant Contact HSIU-PING HUANG
Correspondent
Taiwan Surgical Corporation
3f., # 12. Sec 2, Shengyi Rd.
Zhubei City,  TW 30261
Correspondent Contact HSIU-PING HUANG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/03/2015
Decision Date 04/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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