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510(k) K080039

PASSIVE WASTE GAS SCAVENGER, MODEL 14600 by G. Dundas Co.,Inc. — Product Code CBN

K080039 is an FDA 510(k) premarket notification submitted by G. Dundas Co.,Inc. for the device "PASSIVE WASTE GAS SCAVENGER, MODEL 14600". The FDA issued a decision of Substantially Equivalent on April 14, 2008. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. G. Dundas Co.,Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2008
Date Received
January 7, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type

Other clearances by G. Dundas Co.,Inc.

  • K110930 — ACTIVE WASTE GAS SCAVENGER (June 23, 2011)

Other clearances for product code CBN

  • K223452 — Nitronox Scavenger Plus (March 5, 2023)
  • K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2) (December 4, 2020)
  • K160950 — MINISCAV (May 5, 2017)
  • K142138 — ISO-GARD MASK (October 30, 2014)
  • K132729 — ISO-GARD MASK (January 9, 2014)
  • K123176 — ISO-GARD CLEARAIR MASK (February 14, 2013)
  • K110930 — ACTIVE WASTE GAS SCAVENGER (June 23, 2011)
  • K092031 — VAPOR-CLEAR, MODEL 100 (April 16, 2010)
  • K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT (October 18, 2007)
  • K063519 — DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (December 1, 2006)

FDA data resources