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510(k) K910649

MDT/CASTLE 10/90 LOAD STATION by Mdt Biologic Co. — Product Code FLF

K910649 is an FDA 510(k) premarket notification submitted by Mdt Biologic Co. for the device "MDT/CASTLE 10/90 LOAD STATION". The FDA issued a decision of Substantially Equivalent on September 6, 1991. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Mdt Biologic Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1991
Date Received
February 14, 1991
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 Mdt Biologic Co.

  • K954736 — ACCESS (POWERCLAVE) (August 15, 1996)
  • K954940 — MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE (January 17, 1996)
  • K943654 — HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS (August 2, 1995)
  • K911087 — CASTLE WASHER/DISINFECTOR, MODEL 7550 (August 9, 1993)
  • K910777 — MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER (March 27, 1992)
  • K910778 — STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) (October 28, 1991)
  • K910942 — AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT (June 11, 1991)

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)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)

FDA data resources