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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headgear, Extraoral, Orthodontic
510(k) Number K861424
Device Name ADAPTABLE CLASS III MASK
Applicant
Great Lakes Orthodontics, Ltd.
199 Fire Tower Dr.
P.O. Box 5111
Tonawanda,  NY  14151
Applicant Contact VICKIE PLOSCYCA
Correspondent
Great Lakes Orthodontics, Ltd.
199 Fire Tower Dr.
P.O. Box 5111
Tonawanda,  NY  14151
Correspondent Contact VICKIE PLOSCYCA
Regulation Number872.5500
Classification Product Code
DZB  
Date Received04/16/1986
Decision Date 05/29/1986
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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