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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 K082543
Device Name SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
Applicant
Sonocine, Inc.
5475 Reno Corporate Dr.
Suite 200
Reno,  NV  89511
Applicant Contact ROBERT J CHIN
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received09/03/2008
Decision Date 10/14/2008
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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