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. |
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Device | LOGICON CARIES DETECTOR |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | CARESTREAM DENTAL LLC 1765 THE EXCHANGE ATLANTA, GA 30339 |
PMA Number | P980025 |
Supplement Number | S003 |
Date Received | 10/23/2015 |
Decision Date | 12/10/2015 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 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 CARESTREAM DENTAL IN ATLANTA, GEORGIA. |
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