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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Dental
510(k) Number K851524
Device Name SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE
Applicant
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact KINTNER P
Correspondent
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact KINTNER P
Regulation Number872.4730
Classification Product Code
DZM  
Date Received04/16/1985
Decision Date 09/23/1985
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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