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510(k) K974661

0.2 U BACTERIAL FILTER by Sims Deltec, Inc. — Product Code FPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1998
Date Received
December 15, 1997
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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  • K991599 — CADD ADMINISTRATION SET (June 15, 1999)
  • K991301 — CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPH (June 9, 1999)
  • K991255 — CADD-TPN ADMINISTRATION SET, MODEL 21-7071 (June 9, 1999)
  • K990083 — CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECU (February 12, 1999)

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  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)
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