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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 K013587
Device Name BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
Applicant
Babies Best, Inc.
3825 S. Sante Fe Ave.
Vernon,  CA  90058
Applicant Contact JAY SALKIN
Correspondent
Babies Best, Inc.
3825 S. Sante Fe Ave.
Vernon,  CA  90058
Correspondent Contact JAY SALKIN
Regulation Number872.5550
Classification Product Code
KKO  
Date Received10/30/2001
Decision Date 05/14/2002
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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