510(k) K200096

Crosstex VH2O2 Chemical Indicators by Crosstex International, Inc. (A Cantel Medical Company) — Product Code JOJ

K200096 is an FDA 510(k) premarket notification submitted by Crosstex International, Inc. (A Cantel Medical Company) for the device "Crosstex VH2O2 Chemical Indicators". The FDA issued a decision of Substantially Equivalent on Jul 15, 2021. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 15, 2021
Date Received
Jan 16, 2020
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
510(k)