510(k) K210866

Steri-Dot Process Indicator by Propper Manufacturing Co., Inc. — Product Code JOJ

K210866 is an FDA 510(k) premarket notification submitted by Propper Manufacturing Co., Inc. for the device "Steri-Dot Process Indicator". The FDA issued a decision of Substantially Equivalent on June 21, 2021. 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
June 21, 2021
Date Received
March 23, 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