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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K982671
Device Name SECURALLOY
Applicant
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036 -5339
Applicant Contact PETER S REICHERTZ
Correspondent
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036 -5339
Correspondent Contact PETER S REICHERTZ
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received07/31/1998
Decision Date 10/19/1998
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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