The following data is part of a premarket notification filed by Elitechgroup Inc. with the FDA for Macroduct Advanced Model 3710.
| Device ID | K180627 |
| 510k Number | K180627 |
| Device Name: | Macroduct Advanced Model 3710 |
| Classification | Device, Iontophoresis, Specific Uses |
| Applicant | ELITechGroup Inc. 370 W 1700 S Logan, UT 84321 |
| Contact | Stacey Pahulu |
| Correspondent | Bryce Mceuen ELITechGroup Inc. 370 W 1700 S Logan, UT 84321 |
| Product Code | KTB |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-03-09 |
| Decision Date | 2018-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661540304347 | K180627 | 000 |
| 03661540304385 | K180627 | 000 |
| 03661540304378 | K180627 | 000 |
| 03661540300363 | K180627 | 000 |
| 03661540300356 | K180627 | 000 |
| 03661540300349 | K180627 | 000 |
| 03661540300370 | K180627 | 000 |