The following data is part of a premarket notification filed by Tepha, Inc. with the FDA for Galaflex Mesh.
| Device ID | K140533 |
| 510k Number | K140533 |
| Device Name: | GALAFLEX MESH |
| Classification | Surgical Film |
| Applicant | TEPHA, INC. 99 HAYDEN, SUTIE 360 Lexington, MA 02421 |
| Contact | Mary P Legraw |
| Correspondent | Mary P Legraw TEPHA, INC. 99 HAYDEN, SUTIE 360 Lexington, MA 02421 |
| Product Code | OOD |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855920006133 | K140533 | 000 |
| 00855920006591 | K140533 | 000 |
| 00855920006690 | K140533 | 000 |
| 00855920006683 | K140533 | 000 |
| 00855920006676 | K140533 | 000 |
| 00855920006669 | K140533 | 000 |
| 00855920006652 | K140533 | 000 |
| 00855920006645 | K140533 | 000 |
| 00855920006638 | K140533 | 000 |
| 00855920006621 | K140533 | 000 |
| 00855920006614 | K140533 | 000 |
| 00855920006584 | K140533 | 000 |
| 00855920006577 | K140533 | 000 |
| 00855920006607 | K140533 | 000 |
| 00855920006003 | K140533 | 000 |
| 00855920006126 | K140533 | 000 |
| 00855920006119 | K140533 | 000 |
| 00855920006102 | K140533 | 000 |
| 00855920006096 | K140533 | 000 |
| 00855920006089 | K140533 | 000 |
| 00855920006072 | K140533 | 000 |
| 00855920006065 | K140533 | 000 |
| 00855920006058 | K140533 | 000 |
| 00855920006041 | K140533 | 000 |
| 00855920006034 | K140533 | 000 |
| 00855920006027 | K140533 | 000 |
| 00855920006010 | K140533 | 000 |
| 00855920006560 | K140533 | 000 |