510(k) K102894

CLASSIX CHEMICAL STERILIZATION INDICATOR by Propper Mfg. Co., Inc. — Product Code JOJ

K102894 is an FDA 510(k) premarket notification submitted by Propper Mfg. Co., Inc. for the device "CLASSIX CHEMICAL STERILIZATION INDICATOR". The FDA issued a decision of Substantially Equivalent on May 25, 2011. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Propper Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2011
Date Received
September 30, 2010
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