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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K033267
Device Name EPRICORD
Applicant
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Applicant Contact SATOSHI YAMAGUCHI
Correspondent
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Correspondent Contact SATOSHI YAMAGUCHI
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/09/2003
Decision Date 12/22/2003
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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