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510(k) K840212

CONCENTRATED PLATELET ADMIN. SET by American Mcgaw — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1984
Date Received
January 19, 1984
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

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  • K843954 — MIXING CONTAINER (November 28, 1984)
  • K841729 — ACCUPRO ENTERAL FEEDING PUMP (June 1, 1984)
  • K840388 — PAB IV CONTAINER (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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