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510(k) K901477

DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION by Delmed, Inc. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1990
Date Received
March 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Delmed, Inc.

  • K895142 — ENTERAL PUMP SET WITH ENTERAL SPIKE (October 2, 1990)
  • K895329 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA (October 2, 1990)
  • K895650 — ENTERAL PUMP SET W/ENTERA-FLO SPIKE (October 2, 1990)
  • K894506 — ENTERA-FLO ENTERAL FEEDING PUMP (August 6, 1990)
  • K901478 — DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION (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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