510(k) K043135

SPSMEDICAL SPORVIEW PA CULTURE SET by Spsmedical Supply Corp. — Product Code MRB

K043135 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "SPSMEDICAL SPORVIEW PA CULTURE SET". The FDA issued a decision of Substantially Equivalent on January 13, 2005. The device falls under product code MRB (Indicator, Biological, Liquid 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 13, 2005
Date Received
November 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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