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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Periodontic
510(k) Number K870280
Device Name ACCUDENT ACCUPROBE
Applicant
Accudent, Inc.
1014 Reservoir St.
Harrisonburg,  VA  22801
Applicant Contact STEPHEN J BROWN,DDS
Correspondent
Accudent, Inc.
1014 Reservoir St.
Harrisonburg,  VA  22801
Correspondent Contact STEPHEN J BROWN,DDS
Regulation Number872.4565
Classification Product Code
EIX  
Date Received01/27/1987
Decision Date 06/08/1987
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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