The following data is part of a premarket notification filed by Mattioli Engineering Corp. with the FDA for Transderm Ionto System, Mk 2.
| Device ID | K042590 |
| 510k Number | K042590 |
| Device Name: | TRANSDERM IONTO SYSTEM, MK 2 |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | MATTIOLI ENGINEERING CORP. 11800 BALTIMORE AVENUE SUITE 105 Beltsville, MD 20705 |
| Contact | Melissa Mahall |
| Correspondent | Melissa Mahall MATTIOLI ENGINEERING CORP. 11800 BALTIMORE AVENUE SUITE 105 Beltsville, MD 20705 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-09-23 |
| Decision Date | 2004-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08054383090006 | K042590 | 000 |