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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 K003877
Device Name MAR COR SERVICES SEMPER PURE RO MACHINE
Applicant
MAR COR SERVICES, INC.
364 MAPLE AVE.
HARLEYSVILLE,  PA  19438
Applicant Contact ANDREW G STITZINGER
Correspondent
MAR COR SERVICES, INC.
364 MAPLE AVE.
HARLEYSVILLE,  PA  19438
Correspondent Contact ANDREW G STITZINGER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/15/2000
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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