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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 K870765
Device Name CANNULATED INSTRUMENT CLEANERS
Applicant
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Applicant Contact THOMAS, JR
Correspondent
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Correspondent Contact THOMAS, JR
Regulation Number872.4565
Classification Product Code
EKW  
Date Received02/26/1987
Decision Date 05/27/1987
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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