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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subsystem, Water Purification
510(k) Number K952215
Device Name SERIM HISENSE TEST KIT
Applicant
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Applicant Contact ROBERT C BOGUSLASKI
Correspondent
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Correspondent Contact ROBERT C BOGUSLASKI
Regulation Number876.5665
Classification Product Code
FIP  
Date Received05/11/1995
Decision Date 08/09/1995
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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