510(k) K160730

Instrument kits by Anthogyr — Product Code KCT

K160730 is an FDA 510(k) premarket notification submitted by Anthogyr for the device "Instrument kits". The FDA issued a decision of Substantially Equivalent on April 27, 2017. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Anthogyr has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2017
Date Received
March 16, 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