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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K113680
Device Name SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
Applicant
SOMA ACCESS SYSTEMS LLC
109 LAUREN ROAD, SUITE 4C
GREENVILLE,  SC  29607
Applicant Contact GENOA ATWOOD
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received12/15/2011
Decision Date 12/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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