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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 K955069
Device Name PLAYSKOOL
Applicant
Hasbro, Inc.
1029 Newport Ave.
P.O. Box 1059
Pawtucket,  RI  02862
Applicant Contact CHARLES J FISCHER
Correspondent
Hasbro, Inc.
1029 Newport Ave.
P.O. Box 1059
Pawtucket,  RI  02862
Correspondent Contact CHARLES J FISCHER
Regulation Number872.5550
Classification Product Code
KKO  
Date Received11/06/1995
Decision Date 12/22/1995
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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