The following data is part of a premarket notification filed by C. R. Bard Inc with the FDA for Phasix St Mesh.
Device ID | K173143 |
510k Number | K173143 |
Device Name: | Phasix ST Mesh |
Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
Applicant | C. R. Bard Inc 100 Crossings Boulevard Warwick, RI 02886 |
Contact | Tony John |
Correspondent | Tony John C. R. Bard Inc 100 Crossings Boulevard Warwick, RI 02886 |
Product Code | OWT |
Subsequent Product Code | FTL |
Subsequent Product Code | OOD |
Subsequent Product Code | OWZ |
Subsequent Product Code | OXC |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2018-04-25 |
Summary: | summary |