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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Post, Root Canal
510(k) Number K020431
Device Name FIBIOCORE
Applicant
Est. Anthogyr
164 Rue Des Trois Lacs
Sallanches,  FR 74700
Applicant Contact CLAUDE ANTHOINE
Correspondent
Est. Anthogyr
164 Rue Des Trois Lacs
Sallanches,  FR 74700
Correspondent Contact CLAUDE ANTHOINE
Regulation Number872.3810
Classification Product Code
ELR  
Date Received02/08/2002
Decision Date 07/03/2002
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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