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510(k) K032801

MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR by Albert Browne , Ltd. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2003
Date Received
September 9, 2003
Clearance Type
Special
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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  • 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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