510(k) K992767

BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR by Albert Browne , Ltd. — Product Code JOJ

K992767 is an FDA 510(k) premarket notification submitted by Albert Browne , Ltd. for the device "BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR". The FDA issued a decision of Substantially Equivalent on Jan 10, 2000. 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
Jan 10, 2000
Date Received
Aug 17, 1999
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