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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Teething, Fluid-Filled
510(k) Number K052105
Device Name WATER FILLED TEETHER
Applicant
Royal Industries (Thailand) Public Co. , Ltd.
126, Moo 6 Sethakit 1, Rd.,
Omnoi,
Krathumban,  TH 74130
Applicant Contact ANDREW SIMS
Correspondent
Royal Industries (Thailand) Public Co. , Ltd.
126, Moo 6 Sethakit 1, Rd.,
Omnoi,
Krathumban,  TH 74130
Correspondent Contact ANDREW SIMS
Regulation Number872.5550
Classification Product Code
KKO  
Date Received08/03/2005
Decision Date 10/31/2005
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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