510(k) K203458

3M Comply Hydrogen Peroxide Chemical Indicator 1248 by 3M Company — Product Code JOJ

K203458 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Comply Hydrogen Peroxide Chemical Indicator 1248". The FDA issued a decision of Substantially Equivalent on Dec 11, 2020. 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 334 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 11, 2020
Date Received
Nov 24, 2020
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
510(k)