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510(k) K792649

UNISPORE-BIOLOGICAL INDICATORS by Castle Co. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1980
Date Received
December 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

Other clearances by Castle Co.

  • K870975 — MODIFIED CASTLE POWERCLAVE (April 17, 1987)
  • K860263 — CASTLE 7538 FLOOR LOADING WASHER (March 5, 1986)
  • K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER (January 14, 1985)
  • K834048 — BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO (April 4, 1984)
  • K833074 — CASTLE TEC-TEST S.M.A.R.T. PACK (November 7, 1983)
  • K831595 — CASTLE MODEL 3341 & 3441 & 4141 GAS AER (June 15, 1983)
  • K792660 — 1500 EO EXHAUST HOOD (January 29, 1980)
  • K790677 — EO EVACUATING SYSTEM I (May 7, 1979)
  • K781887 — 9100 DAYSTAR AND 9110 ORBITER PACKAGE (December 12, 1978)
  • K781484 — CASTLE MODEL 3146 GAS AERATOR (October 27, 1978)

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