510(k) K090650

SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS by Spsmedical Supply Corp. — Product Code JOJ

K090650 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS". The FDA issued a decision of Substantially Equivalent on October 9, 2009. 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
October 9, 2009
Date Received
March 11, 2009
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