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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 K082824
Device Name FLUID FILLED TEETHER
Applicant
Kids II
555 N. Point Center
Suite 600
Alpharetta,  GA  30022
Applicant Contact BILL YUNG
Correspondent
Kids II
555 N. Point Center
Suite 600
Alpharetta,  GA  30022
Correspondent Contact BILL YUNG
Regulation Number872.5550
Classification Product Code
KKO  
Date Received09/25/2008
Decision Date 05/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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