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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K894883
Device Name PHYCON ALL SILICONE BALLOON CATHETER
Applicant
VITAID, LTD.
P.O. BOX 123
POSTAL STATION S., TORONTO
ONTARIO, CANADA,  CA M5M 4L6
Applicant Contact WILLIAM G STEWART
Correspondent
VITAID, LTD.
P.O. BOX 123
POSTAL STATION S., TORONTO
ONTARIO, CANADA,  CA M5M 4L6
Correspondent Contact WILLIAM G STEWART
Regulation Number876.5130
Classification Product Code
EZL  
Date Received08/01/1989
Decision Date 04/25/1990
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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