510(k) K082620

ONCE-A-DAY VERTOS TEST PACK by Propper Mfg. Co., Inc. — Product Code JOJ

K082620 is an FDA 510(k) premarket notification submitted by Propper Mfg. Co., Inc. for the device "ONCE-A-DAY VERTOS TEST PACK". The FDA issued a decision of Substantially Equivalent on July 8, 2009. 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
July 8, 2009
Date Received
September 9, 2008
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