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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K984341
Device Name STERNVANTAGE VARNISH LC, MODEL 221001
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 Number872.3760
Classification Product Code
EBI  
Date Received12/04/1998
Decision Date 01/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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