NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
FDA 510(k) clearance K040495 · decided 2004-04-22
Clearance details
- K-number
- K040495
- Device name
- NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
- Applicant
- Naimco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-26
- Decision date
- 2004-04-22
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- EGJ
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chattanooga, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.