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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dam, Rubber
510(k) Number K921771
Device Name MINIDAM II
Applicant
Delsan Dental Systems
108 Howard Way
Pennington,  NJ  08534
Applicant Contact DE LUCA
Correspondent
Delsan Dental Systems
108 Howard Way
Pennington,  NJ  08534
Correspondent Contact DE LUCA
Regulation Number872.6300
Classification Product Code
EIE  
Date Received04/13/1992
Decision Date 09/17/1992
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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