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510(k) K943654

HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS by Mdt Biologic Co. — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1995
Date Received
July 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
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)
  • 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)
  • K910649 — MDT/CASTLE 10/90 LOAD STATION (September 6, 1991)
  • K910942 — AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT (June 11, 1991)

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