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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 K030859
Device Name NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN
Applicant
Enamelite, LLC
1800 Business Park Dr.
Suite 406
Clarksville,  TN  37040
Applicant Contact PHILLIP PITTS
Correspondent
Enamelite, LLC
1800 Business Park Dr.
Suite 406
Clarksville,  TN  37040
Correspondent Contact PHILLIP PITTS
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/18/2003
Decision Date 03/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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