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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K010176
Device Name CALEX CONDITIONER
Applicant
STEPHEN M. KORAL, D.M.D.
2006 BROADWAY
BOULDER,  CO  80302
Applicant Contact STEPHEN M KORAL
Correspondent
STEPHEN M. KORAL, D.M.D.
2006 BROADWAY
BOULDER,  CO  80302
Correspondent Contact STEPHEN M KORAL
Regulation Number872.3250
Classification Product Code
EJK  
Date Received01/18/2001
Decision Date 03/27/2001
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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