510(k) K063799

STEAMPLUS STEAM INTEGRATOR by Spsmedical Supply Corp. — Product Code JOJ

K063799 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "STEAMPLUS STEAM INTEGRATOR". The FDA issued a decision of Substantially Equivalent on January 5, 2007. 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
January 5, 2007
Date Received
December 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type