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510(k) K813201

CASTLE #3241 GAS AERATOR by Sybron Corp. — Product Code FLI

K813201 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "CASTLE #3241 GAS AERATOR". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code FLI (Cabinet, Ethylene-Oxide Gas Aerator), a Class II device regulated under 21 CFR 880.6100. Sybron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
November 13, 1981
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 Sybron Corp.

  • K862284 — SEALITE (June 23, 1986)
  • K854855 — PROOF ALGINATE IMPRESSION MATERIAL (January 30, 1986)
  • K844092 — DIAGNOSTIC MICROSOPCE SLIDES (October 25, 1984)
  • K842132 — TYCOS SELF-CHECK/DIGITAL FEVER THERMO (July 18, 1984)
  • K841910 — KERR SEALAPEX ROOT CANAL SEALER (July 13, 1984)
  • K841732 — LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM (June 5, 1984)
  • K840469 — TYCOS SELF CHECK BPM3 BLOOD PRESS MONI (May 21, 1984)
  • K840407 — KERR RESIN BONDED BRIDGE CEMENT (May 21, 1984)
  • K840607 — LF MOTORIZED RADIOGRAPHIC FILM VIEWER (March 5, 1984)
  • K833138 — DIGITAL INJECTOR SYS (November 14, 1983)

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)
  • K831595 — CASTLE MODEL 3341 & 3441 & 4141 GAS AER (June 15, 1983)
  • K830165 — BEAR JET 150 VENTILATOR (April 12, 1983)
  • 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