Device Classification Name |
graft, vascular, synthetic/biologic composite |
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---|---|---|---|---|
510(k) Number | K122612 | |||
Device Name | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX | |||
Applicant |
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Applicant Contact | marylou insinga | |||
Correspondent |
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Correspodent Contact | marylou insinga | |||
Regulation Number | 870.3450 | |||
Classification Product Code |
|
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Date Received | 08/27/2012 | |||
Decision Date | 09/10/2012 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
Cardiovascular |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |