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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 K963912
Device Name TYCO BABY SESAME STREET SOFT TEETHER
Applicant
Regu-Tech Assoc., Inc.
200 Fifth Ave.,
Rm. 350
New York,  NY  10010
Applicant Contact ROBERT J STAAB
Correspondent
Regu-Tech Assoc., Inc.
200 Fifth Ave.,
Rm. 350
New York,  NY  10010
Correspondent Contact ROBERT J STAAB
Regulation Number872.5550
Classification Product Code
KKO  
Date Received09/30/1996
Decision Date 11/06/1996
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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