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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peritoneal Dialysate Filter
510(k) Number K812615
Device Name TM-CAPD
Applicant
TRI-MED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRI-MED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5630
Classification Product Code
KPP  
Date Received09/15/1981
Decision Date 01/05/1982
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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