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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 K021718
Device Name INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
Applicant
Suni Imaging Microsystems, Inc.
6840 Via Del Oro, Suite 10
San Jose,  CA  95119
Applicant Contact F. AL BETTENCOURT
Correspondent
Suni Imaging Microsystems, Inc.
6840 Via Del Oro, Suite 10
San Jose,  CA  95119
Correspondent Contact F. AL BETTENCOURT
Regulation Number872.1800
Classification Product Code
MUH  
Date Received05/23/2002
Decision Date 08/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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