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510(k) K760491

TUMBLER, GENERAL MEDICAL MEDI-PAK by Landmark Plastics — Product Code LDR

K760491 is an FDA 510(k) premarket notification submitted by Landmark Plastics for the device "TUMBLER, GENERAL MEDICAL MEDI-PAK". The FDA issued a decision of Substantially Equivalent on September 15, 1976. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. Landmark Plastics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1976
Date Received
August 23, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Landmark Plastics

  • K760490 — BEDPAN, GENERAL MEDICAL MEDI-PAK (November 12, 1976)
  • K760517 — CUP, DISPOSABLE MEDICINE (November 12, 1976)
  • K760497 — TRAY, SERVICE (November 12, 1976)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)
  • K760552 — THERMOMETER STAND AND DUST COVER (November 12, 1976)
  • K760496 — CUP, DISPOSABLE SPECIMEN (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760548 — CARAFE AND LINER (November 12, 1976)
  • K760493 — DISH, SOAP (November 12, 1976)

Other clearances for product code LDR

  • K242693 — DEKA Infusion System, DEKA Administration Set (October 7, 2024)
  • K232316 — DEKA Infusion System, DEKA Administration Set (March 1, 2024)
  • K153760 — Volumetric Infusion Controller (October 3, 2016)
  • K963136 — PACER MODEL 100 INFUSION CONTROLLER (October 10, 1997)
  • K971865 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (July 3, 1997)
  • K971826 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (July 3, 1997)
  • K934543 — UNIVERSAL CONTROLLER, MODEL 100 (March 29, 1994)
  • K935236 — FLOW CONTROLLING EXTENSION SET (February 24, 1994)
  • K905498 — STAT 2 IV PUMPETTE (April 16, 1991)
  • K905497 — MASTER FLOW I.V. PUMPETTE (April 16, 1991)

FDA data resources