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510(k) K933294

MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES by Aesculap, Inc. — Product Code FPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1994
Date Received
July 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
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  • K974661 — 0.2 U BACTERIAL FILTER (February 11, 1998)
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  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)