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510(k) K041038

CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER by Churchill Medical Systems, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2004
Date Received
April 22, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

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  • K013950 — VENTED VIAL ACCESS DEVICE (January 10, 2002)
  • K012157 — CHURCHILL MEDICAL SYSTEMS STOPCOCK (September 11, 2001)
  • K011888 — PRESSURE ACTIVATED CHECK VALVE (September 10, 2001)
  • K011336 — PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK (June 12, 2001)
  • K896333 — CMS IV FILTERS (January 11, 1990)
  • K894954 — .22 & 1.2 MICRON IV FILTERS (November 13, 1989)
  • K884370 — CMS IV EXTENSION SETS (November 7, 1988)

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