510(k) K220942
K220942 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)". The FDA issued a decision of Substantially Equivalent on June 24, 2022. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2022
- Date Received
- March 31, 2022
- 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