510(k) K212592
K212592 is an FDA 510(k) premarket notification submitted by Propper Manufacturing Co., Inc. for the device "Gas-Chex Indicator". The FDA issued a decision of Substantially Equivalent on January 20, 2022. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Propper Manufacturing Co., Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 2022
- Date Received
- August 16, 2021
- Clearance Type
- Abbreviated
- 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