510(k) K232924

T-Line® Hernia Mesh by Deep Blue Medical Advances, Inc. — Product Code FTL

K232924 is an FDA 510(k) premarket notification submitted by Deep Blue Medical Advances, Inc. for the device "T-Line® Hernia Mesh". The FDA issued a decision of Substantially Equivalent on October 18, 2023. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Deep Blue Medical Advances, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2023
Date Received
September 19, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type