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510(k) K770136

DISPOSABLE BACTERIA FILTER by Omnicon Medical Corp. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1977
Date Received
January 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Omnicon Medical Corp.

  • K823872 — EMERGENCY TRACHEOSTOMY KIT (January 21, 1983)
  • K820576 — MAINFLOW BACTERIA FILTER (March 18, 1982)
  • K820577 — ANESTHESIA BACTERIA FILTER (March 18, 1982)
  • K801804 — ANESTHESIA BACTERIA FILTER (August 13, 1980)
  • K801803 — MAINFLOW BACTERIA FILTER (August 13, 1980)
  • K772060 — PROTECT IV GARD (December 20, 1977)
  • K770001 — AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S (January 12, 1977)
  • K760819 — CONDUCTIVE ANESTHESIA BREATHING CIRCUIT (October 27, 1976)
  • K760149 — CONDUCTIVE ANESTHSIA BREATH. CIRCUIT (July 19, 1976)

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  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
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  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
  • K221250 — EasyOne Filter (November 22, 2022)
  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)
  • K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (November 16, 2021)
  • K202459 — Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-H (September 26, 2021)