TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE


Device Classification Name

biopsy needle kit

510(k) Number K073399
Device Name TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
Applicant
ENVISIONEERING, LLC.
1982 innerbelt business ctr dr
st. louis, 
MO 
63114

Applicant Contact david kennedy
Correspondent
ENVISIONEERING, LLC.
1982 innerbelt business ctr dr
st. louis, 
MO 
63114

Correspodent Contact david kennedy
Regulation Number 876.1075
Classification Product Code
FCG  
Subsequent Product Code
ITX  
Date Received 12/04/2007
Decision Date 12/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No