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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture, Plastic, Teeth
510(k) Number K771398
Device Name SHELL VENEER
Applicant
L.D. Caulk Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
L.D. Caulk Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3590
Classification Product Code
ELM  
Date Received07/29/1977
Decision Date 08/26/1977
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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