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510(k) K850435

SARTORIUS AQUASART SM 40035 - DIALYSATE SYS by Sartorius Filters, Inc. — Product Code FKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1985
Date Received
February 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Proportioning
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Sartorius Filters, Inc.

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  • K851818 — SARTORIUS MINI SART FH 16592 (August 19, 1985)
  • K844504 — SARTORIUS MINISART SM 16596HY (January 18, 1985)
  • K830487 — HEMO-PROCESSING SYSTEM (April 28, 1983)
  • K823132 — SARTOPHOR SYSTEM FOR ELECTROPHORESIS (November 27, 1982)
  • K822285 — CELLULOSE ACETATE MEMBRANE STRIPS (September 21, 1982)

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