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510(k) K853549

MCGAW/DROP WATCH FLOW MONITOR by American Mcgaw — Product Code FLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
August 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Device Class
Class II
Regulation Number
880.2420
Review Panel
HO
Submission Type

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  • 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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