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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K130678
Device Name BIOMARC GOLD FIDUCIAL MARKER
Applicant
Carbon Medical Technologies, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact ANDREW J ADAMS
Correspondent
Carbon Medical Technologies, Inc.
1290 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact ANDREW J ADAMS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/13/2013
Decision Date 04/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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