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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 K052513
Device Name BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
Applicant
DELTA ENTERPRISE CORPORATION
17 STATE STREET, 19TH FLOOR
NEW YORK,  NY  10004
Applicant Contact MARIA E CELIS
Correspondent
DELTA ENTERPRISE CORPORATION
17 STATE STREET, 19TH FLOOR
NEW YORK,  NY  10004
Correspondent Contact MARIA E CELIS
Regulation Number872.5550
Classification Product Code
KKO  
Date Received09/14/2005
Decision Date 06/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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