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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Caries Detection
510(k) Number K913405
Device Name KAR-D-TEK
Applicant
Gresco Products, Inc.
P.O. Box 865
12603 Executive Dr. #814
Stafford,  TX  77497
Applicant Contact CLINTON D VAUPEL
Correspondent
Gresco Products, Inc.
P.O. Box 865
12603 Executive Dr. #814
Stafford,  TX  77497
Correspondent Contact CLINTON D VAUPEL
Regulation Number872.1740
Classification Product Code
LFC  
Date Received07/30/1991
Decision Date 10/28/1991
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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