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510(k) K820783

CASTLE MICROCOMPUTER STERILIZER CONTROL by Sybron Corp. — Product Code FLF

K820783 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "CASTLE MICROCOMPUTER STERILIZER CONTROL". The FDA issued a decision of Substantially Equivalent on April 15, 1982. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Sybron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1982
Date Received
March 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
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 FLF

  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)
  • K150646 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 18, 2015)
  • K142034 — 3M STERI-VAC STERILIZER/AERATOR (January 8, 2015)
  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (December 2, 2009)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)
  • K020875 — TSO3 OZONE STERILIZER, MODEL 125L (August 26, 2003)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (June 25, 2003)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)

FDA data resources