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FDA 510(k) Application Details - K173694
Device Classification Name
More FDA Info for this Device
510(K) Number
K173694
Device Name
STERIZONE VP4 Sterilizer
Applicant
TSO3, Inc.
2505, Rue Dalton
Quebec G1P 3S5 CA
Other 510(k) Applications for this Company
Contact
Alexandre Jokci
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PJJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2017
Decision Date
03/13/2018
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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