510(k) K112090

BAHADIR STERILIZATION TRAYS by Bahadir USA Corp. — Product Code KCT

K112090 is an FDA 510(k) premarket notification submitted by Bahadir USA Corp. for the device "BAHADIR STERILIZATION TRAYS". The FDA issued a decision of Substantially Equivalent on June 7, 2012. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Bahadir USA Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2012
Date Received
July 21, 2011
Clearance Type
Abbreviated
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