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510(k) K020544

WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA by Churchill Medical Systems, Inc. — Product Code FPA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 12, 2002
Date Received: February 15, 2002
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Set, Administration, Intravascular
Device Class: Class II
Regulation Number: 880.5440
Review Panel: HO
Submission Type

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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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