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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Pulp Canal, Endodontic
510(k) Number K892894
Device Name S-FILE, S-FINDER, S-ENGINE FILE
Applicant
Svenska Dental Instruments AB
P.O. Box 1432
S-171 27 Solna
Sweden,  SE
Applicant Contact AREA MANAGER
Correspondent
Svenska Dental Instruments AB
P.O. Box 1432
S-171 27 Solna
Sweden,  SE
Correspondent Contact AREA MANAGER
Regulation Number872.4565
Classification Product Code
EKS  
Date Received04/20/1989
Decision Date 05/24/1989
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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