510(k) K110682

STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS by Case Medical, Inc. — Product Code KCT

K110682 is an FDA 510(k) premarket notification submitted by Case Medical, Inc. for the device "STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS". The FDA issued a decision of Substantially Equivalent on July 1, 2011. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Case Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2011
Date Received
March 10, 2011
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