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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K951075
Device Name S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
Applicant
S & C Polymer GmbH
Robert-Bosch-Str.5
Elmshorn,  DE D-25335
Applicant Contact JURGEN ENGLEBRECHT
Correspondent
S & C Polymer GmbH
Robert-Bosch-Str.5
Elmshorn,  DE D-25335
Correspondent Contact JURGEN ENGLEBRECHT
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/09/1995
Decision Date 03/31/1995
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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