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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 K142894
Device Name TCS Blend
Applicant
Thermoplastic Comfort Systems, Inc.
2619 Lime Avenue
signal hill,  CA  90755
Applicant Contact marilin posca
Correspondent
Thermoplastic Comfort Systems, Inc.
2619 Lime Avenue
signal hill,  CA  90755
Correspondent Contact marilin posca
Regulation Number872.3760
Classification Product Code
EBI  
Date Received10/03/2014
Decision Date 02/03/2015
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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