510(k) K041017

SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK by Spsmedical Supply Corp. — Product Code JOJ

K041017 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK". The FDA issued a decision of Substantially Equivalent on June 25, 2004. 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
June 25, 2004
Date Received
April 20, 2004
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