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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Alloy, Metal, Base
510(k) Number K854495
Device Name GRESCO N.P. DENTAL ALLOY
Applicant
Gresco Products, Inc.
12603 Executive Dr.
P.O. Box 865
Stafford,  TX  77477
Applicant Contact CLINTON D VAUPEL
Correspondent
Gresco Products, Inc.
12603 Executive Dr.
P.O. Box 865
Stafford,  TX  77477
Correspondent Contact CLINTON D VAUPEL
Regulation Number872.3710
Classification Product Code
EJH  
Date Received11/12/1985
Decision Date 12/27/1985
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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