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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 K801415
Device Name LATEX FOLEY CATHETER (HYDROMER COATED)
Applicant
G.D. Searle and Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
G.D. Searle and Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5130
Classification Product Code
KOD  
Date Received06/16/1980
Decision Date 08/20/1980
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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