GDC ULTRASOFT COIL


Device Classification Name

device, neurovascular embolization

510(k) Number K002181
Device Name GDC ULTRASOFT COIL
Original Applicant
BOSTON SCIENTIFIC, TARGET
47900 bayside pkwy.
fremont, 
CA 
94538

Original Contact james leathley
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 07/19/2000
Decision Date 08/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Special
Reviewed by Third Party No

Combination Product

No