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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Excavator, Dental, Operative
510(k) Number K834055
Device Name VANADIUM EXCAVATORS SIZES 0-6
Applicant
HENRY SCHEIN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HENRY SCHEIN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.4565
Classification Product Code
EKC  
Date Received11/23/1983
Decision Date 02/21/1984
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
Recalls CDRH Recalls
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