FDA 510(k), K192955, Penumbra LP Coil System
FDA 510(k), K192955, Penumbra LP Coil System
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510(K) Number: K192955
Device Name: Penumbra LP Coil System
Manufacturer: Penumbra, Inc.
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 10/21/2019
Decision Date: 11/20/2019
Regulation Medical Specialty: Neurology
143 pages (71 pf 214 original pages are fully redacted)