GalaSHAPE 3D
Surgical Film
Tepha, Inc.
The following data is part of a premarket notification filed by Tepha, Inc. with the FDA for Galashape 3d.
Pre-market Notification Details
| Device ID | K161092 |
| 510k Number | K161092 |
| Device Name: | GalaSHAPE 3D |
| Classification | Surgical Film |
| Applicant | Tepha, Inc. 99 Hayden Avenue Lexington, MA 02421 |
| Contact | Connie H Garrison |
| Correspondent | Connie H Garrison Tepha, Inc. 99 Hayden Avenue 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 | 2016-04-18 |
| Decision Date | 2016-08-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810054980261 | K161092 | 000 |
| 00810054980384 | K161092 | 000 |
| 00810054980391 | K161092 | 000 |
| 00810054980407 | K161092 | 000 |
| 00810054980414 | K161092 | 000 |
| 00810054980421 | K161092 | 000 |
| 00810054980438 | K161092 | 000 |
| 00810054980445 | K161092 | 000 |
| 00810054980452 | K161092 | 000 |
| 00810054980377 | K161092 | 000 |
| 00810054980360 | K161092 | 000 |
| 00810054980353 | K161092 | 000 |
| 00810054980278 | K161092 | 000 |
| 00810054980285 | K161092 | 000 |
| 00810054980292 | K161092 | 000 |
| 00810054980308 | K161092 | 000 |
| 00810054980315 | K161092 | 000 |
| 00810054980322 | K161092 | 000 |
| 00810054980339 | K161092 | 000 |
| 00810054980346 | K161092 | 000 |
| 00810054980469 | K161092 | 000 |
| 00810054980476 | K161092 | 000 |
| 00855920006508 | K161092 | 000 |
| 00855920006515 | K161092 | 000 |
| 00855920006522 | K161092 | 000 |
| 00855920006539 | K161092 | 000 |
| 00855920006546 | K161092 | 000 |
| 00855920006553 | K161092 | 000 |
| 00855920006423 | K161092 | 000 |
| 00855920006447 | K161092 | 000 |
| 00855920006492 | K161092 | 000 |
| 00855920006485 | K161092 | 000 |
| 00855920006478 | K161092 | 000 |
| 00810054980483 | K161092 | 000 |
| 00810054980490 | K161092 | 000 |
| 00810054980506 | K161092 | 000 |
| 00810054980513 | K161092 | 000 |
| 00810054980520 | K161092 | 000 |
| 00810054980537 | K161092 | 000 |
| 00855920006430 | K161092 | 000 |
| 00855920006454 | K161092 | 000 |
| 00855920006461 | K161092 | 000 |
Trademark Results [GalaSHAPE 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALASHAPE 3D 86953182 not registered Dead/Abandoned |
Galatea Surgical, Inc. 2016-03-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.