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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, stomal appliance, ostomy
510(k) Number K761340
Device Name OSTOMY KARAYA GUM POWDER
Applicant
HOWMEDICA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOWMEDICA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5900
Classification Product Code
EZR  
Date Received12/28/1976
Decision Date 03/07/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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