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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., No. 12. Sec 2, ShengYi Rd.
Zhubei City,  TW 30261
Applicant Contact HSIU-PING HUANG
Correspondent
TAIWAN SURGICAL CORPORATION
3F., No. 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
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