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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 K092025
Device Name FLUID FILLED TEETHER - GEL
Applicant
KIDS II
555 NORTH POINT CENTER
SUITE 600
ALPHARETTA,  GA  30022
Applicant Contact BOB COUGHLIN
Correspondent
KIDS II
555 NORTH POINT CENTER
SUITE 600
ALPHARETTA,  GA  30022
Correspondent Contact BOB COUGHLIN
Regulation Number872.5550
Classification Product Code
KKO  
Date Received07/06/2009
Decision Date 01/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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