Device Classification Name |
Cutaneous Electrode Stimulator For Urinary Incontinence
|
510(k) Number |
K192357 |
Device Name |
INNOVO |
Applicant |
Atlantic Therapeutics Ltd. |
Parkmore Business Park West |
Galway,
IE
H91 NHT7
|
|
Applicant Contact |
Anne-Marie Keenan |
Correspondent |
Atlantic Therapeutics Ltd. |
Parkmore Business Park West |
Galway,
IE
H91 NHT7
|
|
Correspondent Contact |
Anne-Marie Keenan |
Regulation Number | 876.5330
|
Classification Product Code |
|
Date Received | 08/29/2019 |
Decision Date | 01/16/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|