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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Single Patient
510(k) Number K871218
Device Name MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
Applicant
Hospal Medical Corp.
21 Northfield Ave.
Raritan Center
Edison,  NJ  08837
Applicant Contact J. L FRESSINET
Correspondent
Hospal Medical Corp.
21 Northfield Ave.
Raritan Center
Edison,  NJ  08837
Correspondent Contact J. L FRESSINET
Regulation Number876.5820
Classification Product Code
FKP  
Date Received03/27/1987
Decision Date 04/30/1987
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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