510(k) K130211

AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS by Spsmedical Supply Corp. — Product Code JOJ

K130211 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS". The FDA issued a decision of Substantially Equivalent on July 5, 2013. 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
July 5, 2013
Date Received
January 29, 2013
Clearance Type
Special
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