The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Parietex Composite (pco) Mesh.
| Device ID | K002699 |
| 510k Number | K002699 |
| Device Name: | PARIETEX COMPOSITE (PCO) MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-30 |
| Decision Date | 2001-02-15 |