| Device Classification Name |
catheter, assisted reproduction |
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|---|---|---|---|---|
| 510(k) Number | K131491 | |||
| Device Name | KITAZATO IUI CATHETER | |||
| Applicant |
|
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| Applicant Contact | richard vincins, cba, cqa, rac | |||
| Correspondent |
|
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| Correspodent Contact | richard vincins, cba, cqa, rac | |||
| Regulation Number | 884.6110 | |||
| Classification Product Code |
|
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| Date Received | 05/23/2013 | |||
| Decision Date | 09/11/2013 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Obstetrics/Gynecology |
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| 510k Review Panel |
Obstetrics/Gynecology |
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| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |