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510(k) K993877

NELSON WATER SYSTEMS FOR HEMODIALYSIS by Nelson Environmental Technologies, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2000
Date Received
November 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

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