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510(k) K920930

MDT/CASTLE 10/90 DUAL LOAD STATION by Mdt Corp., Inc. — Product Code FLF

K920930 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "MDT/CASTLE 10/90 DUAL LOAD STATION". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1993
Date Received
February 28, 1992
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 Corp., Inc.

  • K960777 — MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR (May 23, 1996)
  • K942485 — MDT UROLOGY TABLE (August 26, 1994)
  • K942486 — IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE (August 10, 1994)
  • K924380 — MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE (February 16, 1994)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K924955 — MDT/HARVEY MC-8 AND MC-10 (October 15, 1993)
  • K932094 — BOVIE ULTRASONIC SURGICAL ASPIRATOR (July 21, 1993)
  • K931169 — MDT DENTAL CHAIR (May 20, 1993)
  • K922212 — MDT CASTLE BIOSIGN TEST PACK (August 10, 1992)
  • K914758 — MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE (December 19, 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)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)

FDA data resources