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510(k) K990310

CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) by Charter Medical, Ltd. — Product Code CAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1999
Date Received
February 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microfilter, Blood Transfusion
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Charter Medical, Ltd.

  • K000685 — CHARTER MEDICAL NEONATAL SYRINGE SET (August 15, 2000)

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  • K982822 — FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PED (September 30, 1998)
  • K972159 — FENWAL 40 MICRON TRANSFUSION FILTER (July 23, 1997)
  • K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER (February 14, 1997)
  • K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) (April 22, 1996)
  • K955515 — ALPHA MICRON 20 MICROAGGREGATE FILTER (February 12, 1996)
  • K904223 — SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS (October 26, 1990)
  • K904221 — SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS (October 26, 1990)