Device Classification Name |
clip, aneurysm |
|||
---|---|---|---|---|
510(k) Number | K131500 | |||
Device Name | YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS | |||
Applicant |
|
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Applicant Contact | kathy a racosky | |||
Correspondent |
|
|||
Correspodent Contact | kathy a racosky | |||
Regulation Number | 882.5200 | |||
Classification Product Code |
|
|||
Subsequent Product Code |
|
|||
Date Received | 05/24/2013 | |||
Decision Date | 01/24/2014 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Neurology |
|||
510k Review Panel |
Neurology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |