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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Upper Urinary Tract
510(k) Number K890310
Device Name STERILE FOLEY CATHETER
Applicant
Kosan Far East Ent. , Ltd.
Rm. 1606 Sino Centre
582-592 Nathan Rd. Kowloon
Hong Kong,  TW
Applicant Contact SHOZO SAITO
Correspondent
Kosan Far East Ent. , Ltd.
Rm. 1606 Sino Centre
582-592 Nathan Rd. Kowloon
Hong Kong,  TW
Correspondent Contact SHOZO SAITO
Regulation Number876.5130
Classification Product Code
EYC  
Date Received01/23/1989
Decision Date 11/30/1989
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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