TYCO BABY SESAME STREET SOFT TEETHER

Ring, Teething, Fluid-filled

REGU-TECH ASSOC., INC.

The following data is part of a premarket notification filed by Regu-tech Assoc., Inc. with the FDA for Tyco Baby Sesame Street Soft Teether.

Pre-market Notification Details

Device IDK963912
510k NumberK963912
Device Name:TYCO BABY SESAME STREET SOFT TEETHER
ClassificationRing, Teething, Fluid-filled
Applicant REGU-TECH ASSOC., INC. 200 FIFTH AVE., ROOM 350 New York,  NY  10010
ContactRobert J Staab
CorrespondentRobert J Staab
REGU-TECH ASSOC., INC. 200 FIFTH AVE., ROOM 350 New York,  NY  10010
Product CodeKKO  
CFR Regulation Number872.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-30
Decision Date1996-11-06

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