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FDA 510(k), K041163, ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
FDA 510(k), K041163, ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
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510(K) Number: K041163
Device Name: ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
Manufacturer: ISOPURE CORP.
Device Classification Name: Subsystem, Water Purification
Regulation Number: 876.5665
Classification Product Code: FIP
Date Received: 05/03/2004
Decision Date: 10/07/2004
Regulation Medical Specialty: Gastroenterology/Urology
Total Pages: 1,065
Fully Redacted Pages: 605
Content Pages: 460
Device Name: ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
Manufacturer: ISOPURE CORP.
Device Classification Name: Subsystem, Water Purification
Regulation Number: 876.5665
Classification Product Code: FIP
Date Received: 05/03/2004
Decision Date: 10/07/2004
Regulation Medical Specialty: Gastroenterology/Urology
Total Pages: 1,065
Fully Redacted Pages: 605
Content Pages: 460
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