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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 K000249
Device Name SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
Applicant
Schaefer Water Centers
Hwy. 61-67
1555 Comercial Blvd.
Herculaneum,  MO  63048
Applicant Contact MICHAEL J SCHAEFER
Correspondent
Schaefer Water Centers
Hwy. 61-67
1555 Comercial Blvd.
Herculaneum,  MO  63048
Correspondent Contact MICHAEL J SCHAEFER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received01/27/2000
Decision Date 12/11/2000
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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