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FDA 510(k), K010055, COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
FDA 510(k), K010055, COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
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510(K) Number: K010055
Device Name: COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
Manufacturer: COOK VASCULAR, INC.
Device Classification Name: dilator, vessel, for percutaneous catheterization
Regulation Number: 870.1310
Classification Product Code: DRE
Date Received: 01/08/2001
Decision Date: 06/14/2001
Regulation Medical Specialty: Cardiovascular
Device Name: COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
Manufacturer: COOK VASCULAR, INC.
Device Classification Name: dilator, vessel, for percutaneous catheterization
Regulation Number: 870.1310
Classification Product Code: DRE
Date Received: 01/08/2001
Decision Date: 06/14/2001
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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