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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 K871899
Device Name IMPERVA-A
Applicant
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Applicant Contact AKERKAR, PH.D.
Correspondent
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Correspondent Contact AKERKAR, PH.D.
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/15/1987
Decision Date 07/21/1987
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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