510(k) K024293

BOWIE-DICK MINI PAK, MODEL BD 115 by Steritec Products, Inc. — Product Code JOJ

K024293 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "BOWIE-DICK MINI PAK, MODEL BD 115". The FDA issued a decision of Substantially Equivalent on August 11, 2003. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steritec Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2003
Date Received
December 24, 2002
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