The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Composite Mono Pm Mesh.
Device ID | K081126 |
510k Number | K081126 |
Device Name: | PARIETEX COMPOSITE MONO PM MESH |
Classification | Mesh, Surgical, Polymeric |
Applicant | SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
Contact | Sharon Alexander |
Correspondent | Sharon Alexander SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2008-04-21 |
Decision Date | 2008-08-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521177789 | K081126 | 000 |
10884521177772 | K081126 | 000 |
10884521177765 | K081126 | 000 |
10884521177758 | K081126 | 000 |