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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K860855
Device Name SHUR GEL 4
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 Number872.3660
Classification Product Code
ELW  
Date Received03/07/1986
Decision Date 06/16/1986
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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