The following data is part of a premarket notification filed by Microlab Americas Inc with the FDA for Acthyderm.
| Device ID | K083016 |
| 510k Number | K083016 |
| Device Name: | ACTHYDERM |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | MICROLAB AMERICAS INC 1468 HARWELL AVE Crofton, MD 2114 |
| Contact | E J Smith |
| Correspondent | E J Smith MICROLAB AMERICAS INC 1468 HARWELL AVE Crofton, MD 2114 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-09 |
| Decision Date | 2009-06-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACTHYDERM 78465222 3784825 Dead/Cancelled |
Zeldin, Jeffrey, A. 2004-08-10 |