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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K781433
Device Name AKRON MALE EXTERNAL CATHETER
Applicant
LATEX IND., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LATEX IND., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5250
Classification Product Code
KNX  
Date Received08/21/1978
Decision Date 11/03/1978
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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