510(k) K162948

Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials by Kerr Corporation — Product Code MVL

K162948 is an FDA 510(k) premarket notification submitted by Kerr Corporation for the device "Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials". The FDA issued a decision of Substantially Equivalent on August 8, 2017. The device falls under product code MVL (Cord, Retraction), a Class U device. Kerr Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2017
Date Received
October 21, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type