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510(k) K103126

TROPHON CHEMICAL INDICATOR by Nanosonics Limited — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2011
Date Received
October 22, 2010
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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