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510(k) K895919

ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III by Delmed, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1990
Date Received
October 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
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)
  • K894506 — ENTERA-FLO ENTERAL FEEDING PUMP (August 6, 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)
  • 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)
  • K895246 — FRENTA(R) DUO-SET (May 2, 1990)

Other clearances for product code KNT

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  • K242901 — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN (January 10, 2025)
  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)