PRECLUDE MVP DURA SUBSTITUTE


Device Classification Name

dura substitute

510(k) Number K021477
Device Name PRECLUDE MVP DURA SUBSTITUTE
Original Applicant
W. L. GORE & ASSOCIATES, INC.
3450 west kiltie ln.
flagstaff, 
AZ 
86001

Original Contact timothy j rynn
Regulation Number 882.5910
Classification Product Code
GXQ  
Date Received 05/08/2002
Decision Date 11/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No