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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Broach, Endodontic
510(k) Number K831749
Device Name ENDODONTIC BROACH(76EKN) BARBED BROACH
Applicant
Union Branch
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Union Branch
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4565
Classification Product Code
EKW  
Date Received05/23/1983
Decision Date 07/12/1983
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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