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510(k) K991418

BROWNE MVI ETHYLENE OXIDE INDICATOR by Albert Browne , Ltd. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1999
Date Received
April 23, 1999
Clearance Type
Abbreviated
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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  • 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)

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