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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name resin, denture, relining, repairing, rebasing
510(k) Number K081537
Device Name CFS FLEXIBLE
Applicant
COMFORT AND FLEXIBLE SYSTEMS
845 ARONSON LAKE COURT
ROSWELL,  GA  30075
Applicant Contact JAY MANSOUR
Correspondent
COMFORT AND FLEXIBLE SYSTEMS
845 ARONSON LAKE COURT
ROSWELL,  GA  30075
Correspondent Contact JAY MANSOUR
Regulation Number872.3760
Classification Product Code
EBI  
Date Received06/02/2008
Decision Date 01/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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