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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, Extraoral Source, Digital
510(k) Number K070219
Device Name SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM
Applicant
Suni Medical Imaging, Inc.
38 Miller Ave. Pmb 170
Mill Valley,  CA  94941
Applicant Contact DAVID STARK
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131 -1230
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number872.1800
Classification Product Code
MUH  
Date Received01/23/2007
Decision Date 02/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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