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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 Dialysis, Single Use
510(k) Number K910787
Device Name TITANIUM CONNECTOR (2 PART)
Applicant
Accurate Surgical Instruments Co.
590 Richmond St. W.
Toronto Canado M5v 1y9,  CA M5V 1Y9
Applicant Contact HELEN MORELAND
Correspondent
Accurate Surgical Instruments Co.
590 Richmond St. W.
Toronto Canado M5v 1y9,  CA M5V 1Y9
Correspondent Contact HELEN MORELAND
Regulation Number876.5630
Classification Product Code
FKO  
Date Received02/25/1991
Decision Date 08/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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