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510(k) K820133

MCGAW FAT EMULSION SET by American Mcgaw — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1982
Date Received
January 18, 1982
Clearance Type
Traditional
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

Other clearances by American Mcgaw

  • K853549 — MCGAW/DROP WATCH FLOW MONITOR (November 12, 1985)
  • K843639 — ADD-A-VIAL SOLUTION TRANSFER DEVICE (January 14, 1985)
  • K843954 — MIXING CONTAINER (November 28, 1984)
  • 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)
  • K813092 — ACCUPRO I.V. ADMINISTRATION SET (December 31, 1981)
  • K810683 — CAPD CATHETER ADAPTER (May 8, 1981)

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