510(k) K142109

STERILUCENT STERILIZATION CONTAINER SYSTEM by Sterilucent, Inc. — Product Code KCT

K142109 is an FDA 510(k) premarket notification submitted by Sterilucent, Inc. for the device "STERILUCENT STERILIZATION CONTAINER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 20, 2015. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Sterilucent, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2015
Date Received
August 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type