The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Composite Ventral Patch.
Device ID | K120506 |
510k Number | K120506 |
Device Name: | PARIETEX COMPOSITE VENTRAL PATCH |
Classification | Mesh, Surgical, Polymeric |
Applicant | SOFRADIM PRODUCTION 15 CROSBY DR Bedford, MA 01730 |
Contact | James Mcmahon |
Correspondent | James Mcmahon SOFRADIM PRODUCTION 15 CROSBY DR Bedford, MA 01730 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-21 |
Decision Date | 2012-06-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521165724 | K120506 | 000 |
10884521514164 | K120506 | 000 |
10884521514157 | K120506 | 000 |
10884521514140 | K120506 | 000 |
10884521165717 | K120506 | 000 |
10884521165700 | K120506 | 000 |