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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLOGICON CARIES DETECTOR
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
CARESTREAM DENTAL LLC
1765 the exchange
atlanta, GA 30339
PMA NumberP980025
Supplement NumberS001
Date Received05/25/2006
Decision Date01/12/2007
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT GA INDUSTRIES, RANCHO PALOS VERDES, CALIFORNIA.
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