510(k) K220942

3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) by 3M Company — Product Code JOJ

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