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510(k) K831595

CASTLE MODEL 3341 & 3441 & 4141 GAS AER by Castle Co. — Product Code FLI

K831595 is an FDA 510(k) premarket notification submitted by Castle Co. for the device "CASTLE MODEL 3341 & 3441 & 4141 GAS AER". The FDA issued a decision of Substantially Equivalent on June 15, 1983. The device falls under product code FLI (Cabinet, Ethylene-Oxide Gas Aerator), a Class II device regulated under 21 CFR 880.6100. Castle Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1983
Date Received
May 17, 1983
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 Castle Co.

  • K870975 — MODIFIED CASTLE POWERCLAVE (April 17, 1987)
  • K860263 — CASTLE 7538 FLOOR LOADING WASHER (March 5, 1986)
  • K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER (January 14, 1985)
  • K834048 — BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO (April 4, 1984)
  • K833074 — CASTLE TEC-TEST S.M.A.R.T. PACK (November 7, 1983)
  • K792649 — UNISPORE-BIOLOGICAL INDICATORS (January 29, 1980)
  • K792660 — 1500 EO EXHAUST HOOD (January 29, 1980)
  • K790677 — EO EVACUATING SYSTEM I (May 7, 1979)
  • K781887 — 9100 DAYSTAR AND 9110 ORBITER PACKAGE (December 12, 1978)
  • K781484 — CASTLE MODEL 3146 GAS AERATOR (October 27, 1978)

Other clearances for product code FLI

  • K904921 — STERI-VAC(TM) AERATOR MODEL XL (December 5, 1990)
  • K902906 — GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR (October 15, 1990)
  • 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