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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 K011277
Device Name HARD RELINER
Applicant
S & C Polymer GmbH
Robert-Bosch-Strasse 5
Elmshorn,  DE D-25335
Applicant Contact JURGEN ENGELBRECHT
Correspondent
S & C Polymer GmbH
Robert-Bosch-Strasse 5
Elmshorn,  DE D-25335
Correspondent Contact JURGEN ENGELBRECHT
Regulation Number872.3760
Classification Product Code
EBI  
Date Received04/26/2001
Decision Date 06/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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