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510(k) K984613

BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION by Albert Browne , Ltd. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1999
Date Received
December 29, 1998
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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  • 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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