510(k) K042590
K042590 is an FDA 510(k) premarket notification submitted by Mattioli Engineering Corp. for the device "TRANSDERM IONTO SYSTEM, MK 2". The FDA issued a decision of Substantially Equivalent on October 14, 2004. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Mattioli Engineering Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 2004
- Date Received
- September 23, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Iontophoresis, Other Uses
- Device Class
- Class II
- Regulation Number
- 890.5525
- Review Panel
- PM
- Submission Type