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510(k) K894506

ENTERA-FLO ENTERAL FEEDING PUMP by Delmed, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1990
Date Received
July 19, 1989
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 Delmed, Inc.

  • K895650 — ENTERAL PUMP SET W/ENTERA-FLO SPIKE (October 2, 1990)
  • K895329 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA (October 2, 1990)
  • K895142 — ENTERAL PUMP SET WITH ENTERAL SPIKE (October 2, 1990)
  • K901478 — DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION (July 27, 1990)
  • K901477 — DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION (July 27, 1990)
  • K900106 — CLOSED DISCONNECT SYSTEM (July 16, 1990)
  • K895919 — ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III (May 2, 1990)
  • K895933 — ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III (May 2, 1990)
  • K895246 — FRENTA(R) DUO-SET (May 2, 1990)
  • K895330 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA (May 2, 1990)

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