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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 K925275
Device Name SOFT DENTURE RELINE MATERIAL ELASTOLINE
Applicant
Great Lakes Orthodontics, Ltd.
199 Fire Tower Dr.
P.O. Box 5111
Tonawanda,  NY  14151
Applicant Contact STEPHEN P WARUNEK
Correspondent
Great Lakes Orthodontics, Ltd.
199 Fire Tower Dr.
P.O. Box 5111
Tonawanda,  NY  14151
Correspondent Contact STEPHEN P WARUNEK
Regulation Number872.3760
Classification Product Code
EBI  
Date Received10/20/1992
Decision Date 01/11/1993
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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