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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 K092494
Device Name GEL FILLED GUM SOOTHER
Applicant
Luv N' Care, Ltd.
3030 Aurora Ave., 2nd Floor
Monroe,  LA  71201
Applicant Contact JOSEPH H HAKIM
Correspondent
Luv N' Care, Ltd.
3030 Aurora Ave., 2nd Floor
Monroe,  LA  71201
Correspondent Contact JOSEPH H HAKIM
Regulation Number872.5550
Classification Product Code
KKO  
Date Received08/14/2009
Decision Date 03/01/2010
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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