510(k) K240910

EO Chex Indicator Tape by Propper Manufacturing Co., Inc. — Product Code JOJ

K240910 is an FDA 510(k) premarket notification submitted by Propper Manufacturing Co., Inc. for the device "EO Chex Indicator Tape". The FDA issued a decision of Substantially Equivalent on June 12, 2024. 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 12, 2024
Date Received
April 2, 2024
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