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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K070344
Device Name LIV BREAST SELF EXAMINATION AID
Applicant
Liv International USA, Inc.
5811 Partridge Dr. SW
Rochester,  MN  55902
Applicant Contact PARTICK GORA
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1710
Classification Product Code
IZH  
Date Received02/06/2007
Decision Date 03/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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