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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 K011788
Device Name EVERSTICK
Applicant
Stick Tech , Ltd.
80 Pkwy. W.
Mount Vernon,  NY  10552
Applicant Contact WILLIAM M TROETEL
Correspondent
Stick Tech , Ltd.
80 Pkwy. W.
Mount Vernon,  NY  10552
Correspondent Contact WILLIAM M TROETEL
Regulation Number872.3760
Classification Product Code
EBI  
Date Received06/08/2001
Decision Date 11/05/2001
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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