| Device Classification Name |
stimulator, nerve, transcutaneous, for pain relief |
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|---|---|---|---|---|
| 510(k) Number | K021271 | |||
| Device Name | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3 | |||
| Original Applicant |
|
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| Original Contact | hans reiss | |||
| Regulation Number | 882.5890 | |||
| Classification Product Code |
|
|||
| Date Received | 04/22/2002 | |||
| Decision Date | 02/06/2003 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Neurology |
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| 510k Review Panel |
Neurology |
|||
| statement |
statement |
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| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |