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FDA 510(k), K031949, TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
FDA 510(k), K031949, TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
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510(K) Number: K031949
Device Name: TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
Manufacturer: AMANDA HARTLEY
Device Classification Name: Catheter, Septostomy
Regulation Number: DXF
Classification Product Code: 06/24/2003
Date Received: 12/10/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
Manufacturer: AMANDA HARTLEY
Device Classification Name: Catheter, Septostomy
Regulation Number: DXF
Classification Product Code: 06/24/2003
Date Received: 12/10/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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