The following data is part of a premarket notification filed by Lifecell Corporation with the FDA for Hp Tissue Matrix.
Device ID | K142326 |
510k Number | K142326 |
Device Name: | HP Tissue Matrix |
Classification | Mesh, Surgical |
Applicant | LifeCell Corporation One Millennium Way Branchburg, NJ 08876 |
Contact | Mira Leiwant |
Correspondent | Mira Leiwant LifeCell Corporation One Millennium Way Branchburg, NJ 08876 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-20 |
Decision Date | 2014-12-23 |
Summary: | summary |