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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name denture, plastic, teeth
510(K) Number K122852
Device Name PHYSIOSTAR NFC
Applicant
CANDULOR USA, INC.
175 pineview drive
amherst,  NY  14228
Contact donna marie hartnett
Regulation Number872.3590
Classification Product Code
ELM  
Date Received09/18/2012
Decision Date 12/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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