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510(k) K843954

MIXING CONTAINER by American Mcgaw — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1984
Date Received
October 9, 1984
Clearance Type
Traditional
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

Other clearances by American Mcgaw

  • K853549 — MCGAW/DROP WATCH FLOW MONITOR (November 12, 1985)
  • K843639 — ADD-A-VIAL SOLUTION TRANSFER DEVICE (January 14, 1985)
  • K841729 — ACCUPRO ENTERAL FEEDING PUMP (June 1, 1984)
  • K840388 — PAB IV CONTAINER (March 6, 1984)
  • K840212 — CONCENTRATED PLATELET ADMIN. SET (March 6, 1984)
  • K831716 — CAPD - CATHETER ADAPTER (June 24, 1983)
  • K822240 — ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. (December 30, 1982)
  • K820133 — MCGAW FAT EMULSION SET (April 6, 1982)
  • K813092 — ACCUPRO I.V. ADMINISTRATION SET (December 31, 1981)
  • K810683 — CAPD CATHETER ADAPTER (May 8, 1981)

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