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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Carver, Wax, Dental
510(k) Number K013993
Device Name NEOCALEX
Applicant
Stephen M Koral, Dmd
2006 Broadway
Boulder,  CO  80302
Applicant Contact STEPHEN M KORAL
Correspondent
Stephen M Koral, Dmd
2006 Broadway
Boulder,  CO  80302
Correspondent Contact STEPHEN M KORAL
Regulation Number872.4565
Classification Product Code
EIK  
Date Received12/04/2001
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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