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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 K864736
Device Name AKRO-SIL PLUS
Applicant
Akron Catheter, Inc.
P.O. Box 5356
Akron,  OH  44313
Applicant Contact MARJORIE SKINNER
Correspondent
Akron Catheter, Inc.
P.O. Box 5356
Akron,  OH  44313
Correspondent Contact MARJORIE SKINNER
Regulation Number876.5130
Classification Product Code
KOD  
Date Received12/04/1986
Decision Date 12/24/1986
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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