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510(k) K820063

KEOFEED 500 ENTERIC FEEDING PUMP by Hedeco — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1982
Date Received
January 11, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Hedeco

  • K830497 — PEM-T (April 5, 1983)
  • K822380 — ROMBEAU GASTROSTOMY-JEJUNAL TUBE (September 17, 1982)
  • K812507 — THE KEOFEED STOMACH TUBE (September 14, 1981)

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