510(k) K914264
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- December 20, 1991
- Date Received
- September 23, 1991
- 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