| Device Classification Name |
device, iontophoresis, other uses |
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|---|---|---|---|---|
| 510(k) Number | K991991 | |||
| Device Name | DUPEL IONTOPHORESIS SYSTEM | |||
| Applicant |
|
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| Applicant Contact | kristy k mollner | |||
| Correspondent |
|
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| Correspodent Contact | kristy k mollner | |||
| Regulation Number | 890.5525 | |||
| Classification Product Code |
|
|||
| Date Received | 06/14/1999 | |||
| Decision Date | 09/10/1999 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Physical Medicine |
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| 510k Review Panel |
Neurology |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |