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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, peritoneal, long-term indwelling
510(k) Number K920515
Device Name INSERTION
Applicant
ACCURATE SURGICAL INSTRUMENTS CO.
590 RICHMOND STREET WEST
TORONTO CANADO M5V 1Y9,  CA M5V 1Y9
Applicant Contact ROTHMAN
Correspondent
ACCURATE SURGICAL INSTRUMENTS CO.
590 RICHMOND STREET WEST
TORONTO CANADO M5V 1Y9,  CA M5V 1Y9
Correspondent Contact ROTHMAN
Regulation Number876.5630
Classification Product Code
FJS  
Date Received02/04/1992
Decision Date 05/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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