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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 K950042
Device Name SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER
Applicant
Accurate Surgical Instruments Co.
590 Richmond St. W.
Toronto Canado M5v 1y9,  CA M5V 1Y9
Applicant Contact D ROTHMAN
Correspondent
Accurate Surgical Instruments Co.
590 Richmond St. W.
Toronto Canado M5v 1y9,  CA M5V 1Y9
Correspondent Contact D ROTHMAN
Regulation Number876.5630
Classification Product Code
FJS  
Date Received01/05/1995
Decision Date 12/15/1995
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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