Device Classification Name |
stimulator, electrical, non-implantable, for incontinence |
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---|---|---|---|---|
510(k) Number | K121820 | |||
Device Name | INWAVE | |||
Applicant |
|
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Applicant Contact | jim arnold | |||
Correspondent |
|
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Correspodent Contact | jim arnold | |||
Regulation Number | 876.5320 | |||
Classification Product Code |
|
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Date Received | 06/21/2012 | |||
Decision Date | 08/24/2012 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Gastroenterology/Urology |
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510k Review Panel |
Gastroenterology/Urology |
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statement |
statement |
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Type | Abbreviated | |||
Reviewed by Third Party | No | |||
Combination Product |
No |