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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 K001755
Device Name MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
Applicant
Mpw Industrial Water Services, Inc.
2848 Interstate Pkwy.
Brunswick,  OH  44212
Applicant Contact BILL WATSON
Correspondent
Mpw Industrial Water Services, Inc.
2848 Interstate Pkwy.
Brunswick,  OH  44212
Correspondent Contact BILL WATSON
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/09/2000
Decision Date 08/05/2002
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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