510(k) K200096
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)