510(k) K160574

K3PRO SURGICAL TRAY by Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG — Product Code KCT

K160574 is an FDA 510(k) premarket notification submitted by Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG for the device "K3PRO SURGICAL TRAY". The FDA issued a decision of Substantially Equivalent on Dec 20, 2016. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 20, 2016
Date Received
Mar 1, 2016
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
510(k)