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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Other Noble Metal
510(k) Number K832425
Device Name GREAT LAKES PASTE SOLDER
Applicant
Great Lakes Orthodontics, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Great Lakes Orthodontics, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3060
Classification Product Code
EJS  
Date Received07/22/1983
Decision Date 10/04/1983
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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