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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 K934645
Device Name RADWORKS
Applicant
Radworks Corp.
14785 Omicron, Dr.
San Antonio,  TX  78245
Applicant Contact S. BRENT DOVE
Correspondent
Radworks Corp.
14785 Omicron, Dr.
San Antonio,  TX  78245
Correspondent Contact S. BRENT DOVE
Regulation Number872.1810
Classification Product Code
EAP  
Date Received09/21/1993
Decision Date 08/17/1994
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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