The following data is part of a premarket notification filed by C.r. Bard Inc with the FDA for Composix L/p Mesh With Echo Ps Positioning System.
Device ID | K102766 |
510k Number | K102766 |
Device Name: | COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM |
Classification | Mesh, Surgical, Polymeric |
Applicant | C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
Contact | Keti Sino |
Correspondent | Keti Sino C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
Product Code | FTL |
Subsequent Product Code | GCJ |
Subsequent Product Code | OQL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-24 |
Decision Date | 2010-12-16 |
Summary: | summary |