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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K973247
Device Name VINTAGE HALO
Applicant
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025 -1096
Applicant Contact THOMAS D YANKELITIS
Correspondent
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025 -1096
Correspondent Contact THOMAS D YANKELITIS
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/29/1997
Decision Date 10/16/1997
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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