Home / 510(k) Clearances / K902906

510(k) K902906

GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR by Gas-Vak — Product Code FLI

K902906 is an FDA 510(k) premarket notification submitted by Gas-Vak for the device "GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR". The FDA issued a decision of Substantially Equivalent on October 15, 1990. The device falls under product code FLI (Cabinet, Ethylene-Oxide Gas Aerator), a Class II device regulated under 21 CFR 880.6100. Gas-Vak has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1990
Date Received
July 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, Ethylene-Oxide Gas Aerator
Device Class
Class II
Regulation Number
880.6100
Review Panel
HO
Submission Type

Other clearances by Gas-Vak

  • K890438 — GAS-VAK(R), MODEL 300 (August 7, 1989)

Other clearances for product code FLI

  • K904921 — STERI-VAC(TM) AERATOR MODEL XL (December 5, 1990)
  • K831595 — CASTLE MODEL 3341 & 3441 & 4141 GAS AER (June 15, 1983)
  • K830165 — BEAR JET 150 VENTILATOR (April 12, 1983)
  • K813201 — CASTLE #3241 GAS AERATOR (December 31, 1981)
  • K790677 — EO EVACUATING SYSTEM I (May 7, 1979)
  • K781484 — CASTLE MODEL 3146 GAS AERATOR (October 27, 1978)
  • K761341 — PORTAGAS AERATOR (February 28, 1977)

FDA data resources