510(k) K203560
K203560 is an FDA 510(k) premarket notification submitted by Tso3 Inc., Now A Part Of Stryker for the device "STERIZONE VP4 Test Pack". The FDA issued a decision of Substantially Equivalent on Mar 24, 2021. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 24, 2021
- Date Received
- Dec 7, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Biological Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type
- 510(k)