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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 K953604
Device Name SHAPING HEDSTROM N.T.
Applicant
Sybron Dental Specialties, Inc.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact JEFFREY A ANDERSON
Correspondent
Sybron Dental Specialties, Inc.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact JEFFREY A ANDERSON
Regulation Number872.4565
Classification Product Code
EKS  
Date Received08/02/1995
Decision Date 09/28/1995
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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