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510(k) K002741

BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK by Albert Browne , Ltd. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2002
Date Received
September 1, 2000
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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  • K051101 — VERIFY FLASH INTEGRATOR (December 6, 2005)
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  • K032801 — MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR (October 17, 2003)
  • 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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