FDA 510(k), K103305, PENUMBRA EMBOLIZATION COIL SYSTEM

510(K) Number: K103305
Device Name: PENUMBRA EMBOLIZATION COIL SYSTEM
Manufacturer: PENUMBRA, INC.
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 11/09/2010
Decision Date: 01/26/2011
Regulation Medical Specialty: Neurology

62 pages (420 of 482 original pages are fully redacted)