510(k) K101851

VENTRALIGHT ST MESH by Davol Inc., Sub. C. R. Bard, Inc. — Product Code FTL

K101851 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "VENTRALIGHT ST MESH". The FDA issued a decision of Substantially Equivalent on July 15, 2010. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Davol Inc., Sub. C. R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2010
Date Received
July 1, 2010
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