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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Diamond, Dental
510(k) Number K854347
Device Name HYBRID POINTS
Applicant
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Applicant Contact MARTY DYMEK
Correspondent
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Correspondent Contact MARTY DYMEK
Regulation Number872.4535
Classification Product Code
DZP  
Date Received10/29/1985
Decision Date 12/27/1985
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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