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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 K033632
Device Name VARIFLEX
Applicant
Great Lakes Orthodontics, Ltd.
200 Cooper Ave.Dr.
Tonawanda,  NY  14150
Applicant Contact MARK LAUREN
Correspondent
Great Lakes Orthodontics, Ltd.
200 Cooper Ave.Dr.
Tonawanda,  NY  14150
Correspondent Contact MARK LAUREN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received11/19/2003
Decision Date 01/21/2004
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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