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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 K031627
Device Name NANO-TICROWN
Applicant
Nano-Write Corp.
2021 Las Positas Ct.
Suite 121
Livermore,  CA  94551
Applicant Contact KENNETH E KNAPP
Correspondent
California Department of Health Services
P.O. Box 942732 (Ms-357)
Sacramento,  CA  94234
Correspondent Contact ALFREDO J QUATTRONE
Regulation Number872.3710
Classification Product Code
EJH  
Date Received05/27/2003
Decision Date 06/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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