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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dam, Rubber
510(k) Number K863816
Device Name IVORY PREMIUM RUBBER DAM
Applicant
Columbus Dental Mfg. Co.
1000 Chouteau Ave.
P.O. Box 620
St. Louis,  MO  63188
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
Columbus Dental Mfg. Co.
1000 Chouteau Ave.
P.O. Box 620
St. Louis,  MO  63188
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.6300
Classification Product Code
EIE  
Date Received09/30/1986
Decision Date 10/27/1986
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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