510(k) K061754

BARD COMPOSITE L/P MESH by Davol Inc., Sub. C. R. Bard, Inc. — Product Code FTL

K061754 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "BARD COMPOSITE L/P MESH". The FDA issued a decision of Substantially Equivalent on October 23, 2006. 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
October 23, 2006
Date Received
June 21, 2006
Clearance Type
Traditional
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