510(k) K131407

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

K131407 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 August 12, 2014. 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
August 12, 2014
Date Received
May 15, 2013
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