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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Fluoride, Disposable
510(k) Number K031809
Device Name PERIO PROTECT TRAY
Applicant
PERIO PROTECT LLC
1625 MASSACHUSETTS AVENUE NW;
SUITE 300
WASHINGTON,  DC  20036 -2247
Applicant Contact DAVID L ROSEN
Correspondent
PERIO PROTECT LLC
1625 MASSACHUSETTS AVENUE NW;
SUITE 300
WASHINGTON,  DC  20036 -2247
Correspondent Contact DAVID L ROSEN
Regulation Number872.6870
Classification Product Code
KMT  
Date Received06/12/2003
Decision Date 01/23/2004
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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