510(k) K193154

3M Attest Super Rapid 5 Steam-Plus Challenge Pack by 3M Company — Product Code FRC

K193154 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Attest Super Rapid 5 Steam-Plus Challenge Pack". The FDA issued a decision of Substantially Equivalent on Feb 7, 2020. The device falls under product code FRC (Indicator, Biological 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
Feb 7, 2020
Date Received
Nov 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type
510(k)