The following data is part of a premarket notification filed by Inmed Ltda. with the FDA for Lektrogel, Model Lk3001.
| Device ID | K030887 |
| 510k Number | K030887 |
| Device Name: | LEKTROGEL, MODEL LK3001 |
| Classification | Media, Electroconductive |
| Applicant | INMED LTDA. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour INMED LTDA. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-21 |
| Decision Date | 2003-06-13 |
| Summary: | summary |