VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1


Device Classification Name

accessory,barium sulfate,methyl methacrylate for cranioplasty

510(k) Number K024359
Device Name VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1
Original Applicant
VISTA SCIENTIFIC, LLC
7960 niwot rd.
unit b-7
niwot, 
CO 
80503

Original Contact jonathan modine
Regulation Number 882.5300
Classification Product Code
MYU  
Date Received 12/30/2002
Decision Date 08/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No