510(k) K153392
K153392 is an FDA 510(k) premarket notification submitted by Ts03, Inc. for the device "STERIZONE VP4 Sterilizer". The FDA issued a decision of Substantially Equivalent on March 24, 2016. The device falls under product code PJJ (Two Or More Sterilant Sterilizer), a Class II device regulated under 21 CFR 880.6860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2016
- Date Received
- November 24, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Two Or More Sterilant Sterilizer
- Device Class
- Class II
- Regulation Number
- 880.6860
- Review Panel
- HO
- Submission Type
Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.