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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name collector, ostomy
510(k) Number K852471
Device Name CONFIDENT ODOR ELIMINATOR
Applicant
HALLMARK INDUSTRIES, INC.
564 KINGS HWY.
WEST SPRINGFIELD,  MA  01089
Applicant Contact DI ROMA
Correspondent
HALLMARK INDUSTRIES, INC.
564 KINGS HWY.
WEST SPRINGFIELD,  MA  01089
Correspondent Contact DI ROMA
Regulation Number876.5900
Classification Product Code
EXB  
Date Received06/11/1985
Decision Date 01/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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