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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K102573
Device Name PROVU (TM) DENTAL X-RAY SYSTEM
Applicant
Advanced Image Science, Inc.
1999 S. Basom Ave.,
Suite 700
Campbell,  CA  95008
Applicant Contact PAUL ROCKWELL
Correspondent
Advanced Image Science, Inc.
1999 S. Basom Ave.,
Suite 700
Campbell,  CA  95008
Correspondent Contact PAUL ROCKWELL
Regulation Number872.1810
Classification Product Code
EAP  
Date Received09/09/2010
Decision Date 06/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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