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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K900022
Device Name BJ STAR ALL SILICONE FOLEY BALLOON CATHETER
Applicant
B.J. Star, Inc.
P.O. Box 596
722 Jefferson Ave.
Ashland,  OR  97520
Applicant Contact J CRAVEN
Correspondent
B.J. Star, Inc.
P.O. Box 596
722 Jefferson Ave.
Ashland,  OR  97520
Correspondent Contact J CRAVEN
Regulation Number876.5130
Classification Product Code
KOD  
Date Received01/02/1990
Decision Date 03/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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