510(k) K841168

STERILIZATION PROCESS INDICATOR by Parke-Davis Co. — Product Code JOJ

K841168 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "STERILIZATION PROCESS INDICATOR". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Parke-Davis Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
March 19, 1984
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