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510(k) K964283

AUTOPRIME by Arbor Technologies, Inc. — Product Code FPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1997
Date Received
October 28, 1996
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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  • K895859 — CONTAIN(TM) (February 7, 1991)
  • K902167 — CONTAIN(TM) LASER PLUME FILTER (January 4, 1991)
  • K890844 — MICROSEPT 60/20 (June 7, 1989)
  • K874505 — CONTAIN(TM) (May 20, 1988)
  • K864113 — CLYDE (TM) FILTRATION SYSTEM (February 4, 1987)
  • K863162 — VACU-GUARD (August 29, 1986)

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  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)
  • K942625 — 1.2 MICRON AIR ELIMINATING FILTER (October 7, 1994)