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FDA 510(k), K913490, PHOENIX BURR HOLE BUTTON, BURR 1
FDA 510(k), K913490, PHOENIX BURR HOLE BUTTON, BURR 1
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510(K) Number: K913490
Device Name: PHOENIX BURR HOLE BUTTON, BURR 1
Manufacturer: PHOENIX BIOENGINEERING, INC.
Device Classification Name: cover, burr hole
Regulation Number: 882.5250
Classification Product Code: GXR
Date Received: 08/06/1991
Decision Date: 01/13/1992
Regulation Medical Specialty: Neurology
Device Name: PHOENIX BURR HOLE BUTTON, BURR 1
Manufacturer: PHOENIX BIOENGINEERING, INC.
Device Classification Name: cover, burr hole
Regulation Number: 882.5250
Classification Product Code: GXR
Date Received: 08/06/1991
Decision Date: 01/13/1992
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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