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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 K965082
Device Name SOOTHING WATER-FILLED TEETHER
Applicant
Consolidated Stores Corp.
300 Phillipi Rd.
Columbus,  OH  43228
Applicant Contact JOHANN COZART
Correspondent
Consolidated Stores Corp.
300 Phillipi Rd.
Columbus,  OH  43228
Correspondent Contact JOHANN COZART
Regulation Number872.5550
Classification Product Code
KKO  
Date Received12/19/1996
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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