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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Metal, Orthodontic
510(k) Number K930881
Device Name CHANNEL-EDGE BRACKET SYSTEM
Applicant
Dualtek, Inc.
1225 Sherwood Park Dr.
Gainesville,  GA  30501
Applicant Contact JAMES L CANNON
Correspondent
Dualtek, Inc.
1225 Sherwood Park Dr.
Gainesville,  GA  30501
Correspondent Contact JAMES L CANNON
Regulation Number872.5410
Classification Product Code
EJF  
Date Received01/19/1993
Decision Date 01/21/1994
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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