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510(k) K911087

CASTLE WASHER/DISINFECTOR, MODEL 7550 by Mdt Biologic Co.

K911087 is an FDA 510(k) premarket notification submitted by Mdt Biologic Co. for the device "CASTLE WASHER/DISINFECTOR, MODEL 7550". The FDA issued a decision of Substantially Equivalent on August 9, 1993. Mdt Biologic Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1993
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • 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)

FDA data resources