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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K981524
Device Name PRILANE
Applicant
Gresco Products, Inc.
13391 Murphy Rd.
P.O. Box 865
Stafford,  TX  77477
Applicant Contact CLINTON D VAUPEL
Correspondent
Gresco Products, Inc.
13391 Murphy Rd.
P.O. Box 865
Stafford,  TX  77477
Correspondent Contact CLINTON D VAUPEL
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/28/1998
Decision Date 07/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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