Device Classification Name |
catheter, embolectomy |
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---|---|---|---|---|
510(k) Number | K050130 | |||
Device Name | KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM | |||
Applicant |
|
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Applicant Contact | tom mason | |||
Correspondent |
|
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Correspodent Contact | tom mason | |||
Regulation Number | 870.5150 | |||
Classification Product Code |
|
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Date Received | 01/21/2005 | |||
Decision Date | 05/13/2005 | |||
Decision |
se – with limitations (SESU) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
Cardiovascular |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |