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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 K010519
Device Name MAGNUM FLOW IRRIGATION SYSTEM
Applicant
SCION VALLEY, INC.
HWY. 6 NORTH
MERIDIAN,  TX  76665
Applicant Contact C. KENNETH FRENCH
Correspondent
SCION VALLEY, INC.
HWY. 6 NORTH
MERIDIAN,  TX  76665
Correspondent Contact C. KENNETH FRENCH
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HET  
Date Received02/22/2001
Decision Date 05/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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