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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 K820419
Device Name AM. PH. STERILE SINGLE-USE URETHRAL CATH
Applicant
AMERICAN PHARMASEAL DIV. AHSC
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN PHARMASEAL DIV. AHSC
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5130
Classification Product Code
KOD  
Date Received02/16/1982
Decision Date 03/23/1982
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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