The following data is part of a premarket notification filed by American Custom Medical, Inc. with the FDA for Acm Ptfe Surgical Mesh.
| Device ID | K944413 |
| 510k Number | K944413 |
| Device Name: | ACM PTFE SURGICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | AMERICAN CUSTOM MEDICAL, INC. 3305 66TH ST. Lubbock, TX 79413 |
| Contact | Bruce G Ruefer |
| Correspondent | Bruce G Ruefer AMERICAN CUSTOM MEDICAL, INC. 3305 66TH ST. Lubbock, TX 79413 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-08 |
| Decision Date | 1994-11-09 |