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 |