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510(k) K873487

HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES by Water Pure, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
August 31, 1987
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

Other clearances by Water Pure, Inc.

  • K863720 — HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES (October 29, 1986)

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