510(k) K890754

SPORVIEW CULTURE MEDIA by Spsmedical Supply Corp. — Product Code FRC

K890754 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "SPORVIEW CULTURE MEDIA". The FDA issued a decision of Substantially Equivalent on November 17, 1989. The device falls under product code FRC (Indicator, Biological 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
November 17, 1989
Date Received
February 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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