Device Classification Name |
catheter, biliary, diagnostic |
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---|---|---|---|---|
510(k) Number | K010549 | |||
Device Name | BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) | |||
Original Applicant |
|
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Original Contact | scott karler | |||
Regulation Number | 876.5010 | |||
Classification Product Code |
|
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Date Received | 02/26/2001 | |||
Decision Date | 01/18/2002 | |||
Decision |
substantially equivalent – kit (SESK) |
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Regulation Medical Specialty |
Gastroenterology/Urology |
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510k Review Panel |
Gastroenterology/Urology |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |