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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorber, Saliva, Paper
510(k) Number K891354
Device Name ORTHODONTIC COTTON ROLL HOLDERS
Applicant
American Orthodontics
1714 Cambridge Ave.
Sheboygan,  WI  53081
Applicant Contact PAUL RIDDLE
Correspondent
American Orthodontics
1714 Cambridge Ave.
Sheboygan,  WI  53081
Correspondent Contact PAUL RIDDLE
Regulation Number872.6050
Classification Product Code
KHR  
Date Received03/10/1989
Decision Date 04/17/1989
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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