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510(k) K910649

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

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)

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  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)