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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K912473
Device Name ACCU-PLACER TM KIT
Applicant
Hu-Friedy Mfg. Co., Inc.
3232 N Rockwell St.
Chicago,  IL  60618
Applicant Contact BETSY A BROWN
Correspondent
Hu-Friedy Mfg. Co., Inc.
3232 N Rockwell St.
Chicago,  IL  60618
Correspondent Contact BETSY A BROWN
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received06/04/1991
Decision Date 07/24/1991
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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