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510(k) K870626

FREEDOM SET II WITH TRIFLEX VALVE by Delmed, Inc. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1987
Date Received
February 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Delmed, Inc.

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  • K895329 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA (October 2, 1990)
  • K895142 — ENTERAL PUMP SET WITH ENTERAL SPIKE (October 2, 1990)
  • K894506 — ENTERA-FLO ENTERAL FEEDING PUMP (August 6, 1990)
  • K901477 — DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION (July 27, 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)
  • K895330 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA (May 2, 1990)
  • K895933 — ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III (May 2, 1990)

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