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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 K132064
Device Name BIOMARC 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 Received07/03/2013
Decision Date 02/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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