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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 K884515
Device Name BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED
Applicant
Gatewood and Associates, Ltd.
P.O. Box 324
Tacoma,  WA  98401
Applicant Contact ELTON GATEWOOD
Correspondent
Gatewood and Associates, Ltd.
P.O. Box 324
Tacoma,  WA  98401
Correspondent Contact ELTON GATEWOOD
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received10/27/1988
Decision Date 01/10/1989
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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