FDA 510(k), K043371, BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

510(K) Number: K043371
Device Name: BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
Manufacturer: BIOMERIX CORPORATION
Device Classification Name: device, vascular, for promoting embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 12/08/2004
Decision Date: 02/03/2005
Regulation Medical Specialty: Cardiovascular

Total pages: 594
Fully redacted pages: 507
Content pages: 87