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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K984340
Device Name STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
Applicant
Sterngold/Implamed
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact GORDON NELSON
Correspondent
Sterngold/Implamed
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact GORDON NELSON
Regulation Number872.3275
Classification Product Code
EMA  
Date Received12/04/1998
Decision Date 01/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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