510(k) K072563

MILTEX RIGID CONTAINER SYSTEMS by Miltex, Inc. — Product Code KCT

K072563 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "MILTEX RIGID CONTAINER SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 12, 2008. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Miltex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2008
Date Received
September 11, 2007
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