The following data is part of a premarket notification filed by Santerra Medical Technology, Inc. with the FDA for 3d Anatomical Mesh.
| Device ID | K990930 |
| 510k Number | K990930 |
| Device Name: | 3D ANATOMICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SANTERRA MEDICAL TECHNOLOGY, INC. 5451 HILLTOP AVE. Lake Elmo, MN 55042 -9539 |
| Contact | David P Lang |
| Correspondent | David P Lang SANTERRA MEDICAL TECHNOLOGY, INC. 5451 HILLTOP AVE. Lake Elmo, MN 55042 -9539 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-19 |
| Decision Date | 1999-06-17 |
| Summary: | summary |