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510(k) K954736

ACCESS (POWERCLAVE) by Mdt Biologic Co. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1996
Date Received
October 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by Mdt Biologic Co.

  • 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)
  • 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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