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510(k) K063285

RELIANCE CI PROCESS INDICATOR by Albert Browne , Ltd. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2007
Date Received
October 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • 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)
  • K012335 — BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS (October 1, 2001)

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