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510(k) K051056

VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR by Albert Browne , Ltd. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2005
Date Received
April 26, 2005
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 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)
  • 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)
  • K012335 — BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS (October 1, 2001)

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