510(k) K890761

STRIP, STERILIZATION INDICATOR; DRY HEAT by Spsmedical Supply Corp. — Product Code JOJ

K890761 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "STRIP, STERILIZATION INDICATOR; DRY HEAT". The FDA issued a decision of Substantially Equivalent on August 7, 1989. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Spsmedical Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1989
Date Received
February 14, 1989
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