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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cabinet, X-Ray System
510(k) Number K082432
Device Name CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
Applicant
BIOPTICS, INC.
15546 W. GELDING DR.
SURPRISE,  AZ  85379
Applicant Contact PATRICIA WADE
Correspondent
BIOPTICS, INC.
15546 W. GELDING DR.
SURPRISE,  AZ  85379
Correspondent Contact PATRICIA WADE
Regulation Number892.1680
Classification Product Code
MWP  
Date Received08/22/2008
Decision Date 11/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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