BIOMARC FIDUCIAL MARKER


Device Classification Name

accelerator, linear, medical

510(k) Number K110772
Device Name BIOMARC FIDUCIAL MARKER
Applicant
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond rd.
st. paul, 
MN 
55110 -5867

Applicant Contact andrew j adams
Correspondent
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond rd.
st. paul, 
MN 
55110 -5867

Correspodent Contact andrew j adams
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 03/21/2011
Decision Date 04/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No