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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condenser, Amalgam And Foil, Operative
510(k) Number K843901
Device Name ISOSTATIC CONDENSER
Applicant
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Applicant Contact ROBERT MANDLER
Correspondent
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Correspondent Contact ROBERT MANDLER
Regulation Number872.4565
Classification Product Code
EKG  
Date Received10/03/1984
Decision Date 12/03/1984
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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