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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 K093370
Device Name FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
Applicant
FU HONG INDUSTRIES LTD.
5401 S. COTTONWOOD CT
GREENWOOD VILLAGE,  CO  80121
Applicant Contact KEVIN WALLS, RAC
Correspondent
FU HONG INDUSTRIES LTD.
5401 S. COTTONWOOD CT
GREENWOOD VILLAGE,  CO  80121
Correspondent Contact KEVIN WALLS, RAC
Regulation Number872.5550
Classification Product Code
KKO  
Date Received10/29/2009
Decision Date 01/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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