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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 K851388
Device Name SEPTOSIL SILICONE FOR PRECISION IMPRESSION
Applicant
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact PETER S REICHERTZ
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/09/1985
Decision Date 05/29/1985
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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