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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K973776
Device Name REFLECTIONS
Applicant
Cdb Corp.
9201 Industrial Blvd.
Leland,  NC  28451
Applicant Contact SYLVIA C JOYCE
Correspondent
Cdb Corp.
9201 Industrial Blvd.
Leland,  NC  28451
Correspondent Contact SYLVIA C JOYCE
Regulation Number872.5470
Classification Product Code
DYW  
Date Received10/03/1997
Decision Date 11/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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