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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 K984483
Device Name A-SOFT RELINER
Applicant
S & C Polymer GmbH
Robert-Bosch-Str.5
Elmshorn,  DE D-25335
Applicant Contact JURGEN ENGELBRECHT
Correspondent
S & C Polymer GmbH
Robert-Bosch-Str.5
Elmshorn,  DE D-25335
Correspondent Contact JURGEN ENGELBRECHT
Regulation Number872.3760
Classification Product Code
EBI  
Date Received12/16/1998
Decision Date 02/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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