SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
FDA 510(k) clearance K031053 · decided 2003-05-20
Clearance details
- K-number
- K031053
- Device name
- SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
- Applicant
- Selectivemed Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-02
- Decision date
- 2003-05-20
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- EGJ
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mount Vernon, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product i recall (Z-0799-05) | Selectivemed Components Inc | 2005-05-06 |