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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Dental, Intraoral
510(k) Number K880606
Device Name UTILITY WAX STRIPS, CINNAMON
Applicant
Columbus Dental Mfg. Co.
1000 Chouteau Ave.
P.O. Box 620
St. Louis,  MO  63188
Applicant Contact JOHN S FRIERDICH
Correspondent
Columbus Dental Mfg. Co.
1000 Chouteau Ave.
P.O. Box 620
St. Louis,  MO  63188
Correspondent Contact JOHN S FRIERDICH
Regulation Number872.6890
Classification Product Code
EGD  
Date Received02/12/1988
Decision Date 03/24/1988
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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