510(k) K053479

VERIFY DRY HEAT LABEL by Albert Browne , Ltd. — Product Code JOJ

K053479 is an FDA 510(k) premarket notification submitted by Albert Browne , Ltd. for the device "VERIFY DRY HEAT LABEL". The FDA issued a decision of Substantially Equivalent on July 18, 2006. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Albert Browne , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2006
Date Received
December 14, 2005
Clearance Type
Traditional
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