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FDA 510(k) Application Details - K141698
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
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510(K) Number
K141698
Device Name
Indicator, Physical/Chemical Sterilization Process
Applicant
TSO3 INC.
512F NE 81ST STREET, SUITE 110
VANCOUVER, WA 98665 US
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Contact
THOMAS RICHARDS, PH.D.
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Regulation Number
880.2800
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Classification Product Code
JOJ
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More FDA Info for this Product Code
Date Received
06/24/2014
Decision Date
12/17/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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