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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 K040881
Device Name METACRYL
Applicant
GREAT LAKES ORTHODONTICS, LTD.
200 COOPER AVE.
P.O. BOX 5111
TONAWANDA,  NY  14151 -5111
Applicant Contact MARK LAUREN
Correspondent
GREAT LAKES ORTHODONTICS, LTD.
200 COOPER AVE.
P.O. BOX 5111
TONAWANDA,  NY  14151 -5111
Correspondent Contact MARK LAUREN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received04/05/2004
Decision Date 05/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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