PARALLAX TRACER RADIOPAQUE PARTICLES


Device Classification Name

accessory,barium sulfate,methyl methacrylate for cranioplasty

510(k) Number K991893
Device Name PARALLAX TRACER RADIOPAQUE PARTICLES
Applicant
PARALLAX MEDICAL, INC.
453 ravendale dr., suite b
mountain view, 
CA 
94043

Applicant Contact susan g marques
Correspondent
PARALLAX MEDICAL, INC.
453 ravendale dr., suite b
mountain view, 
CA 
94043

Correspodent Contact susan g marques
Regulation Number 882.5300
Classification Product Code
MYU  
Date Received 06/03/1999
Decision Date 08/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No