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510(k) K965154

TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE by Albert Browne , Ltd. — Product Code LRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1997
Date Received
December 23, 1996
Clearance Type
Traditional
Expedited Review
Yes
Third Party Review
No

Device Classification

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

Other clearances by Albert Browne , Ltd.

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  • K053479 — VERIFY DRY HEAT LABEL (July 18, 2006)
  • K060066 — VERIFY 3-10 MIN FLASH INTEGRATOR (March 24, 2006)
  • K060103 — ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS (March 7, 2006)
  • K051101 — VERIFY FLASH INTEGRATOR (December 6, 2005)
  • K051056 — VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR (October 20, 2005)
  • K032801 — MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR (October 17, 2003)
  • K002741 — BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK (July 3, 2002)
  • K002937 — TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (November 5, 2001)

Other clearances for product code LRT

  • K002937 — TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (November 5, 2001)
  • K951113 — CROSS-CHECKS (August 19, 1996)
  • K951703 — TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS (June 28, 1995)
  • K871672 — STERILIZATION INDICATOR FOR FLASH STERILIZATION (June 1, 1987)