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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 K092329
Device Name SOPIX 2
Applicant
Sopro
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Applicant Contact RICK ROSATI
Correspondent
Sopro
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact RICK ROSATI
Regulation Number872.1800
Classification Product Code
MUH  
Date Received08/04/2009
Decision Date 07/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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