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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K943273
Device Name TRI HAWK BUR, FG BUR
Applicant
Tri Hawk Corp.
849 S. Broadway, Rm. 811
Los Angeles,  CA  90014
Applicant Contact SOLEDAD ASHWORTH
Correspondent
Tri Hawk Corp.
849 S. Broadway, Rm. 811
Los Angeles,  CA  90014
Correspondent Contact SOLEDAD ASHWORTH
Regulation Number872.3240
Classification Product Code
EJL  
Date Received07/07/1994
Decision Date 08/01/1994
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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