MAM COOLER

Ring, Teething, Fluid-filled

MAM INTERNATIONAL AG

The following data is part of a premarket notification filed by Mam International Ag with the FDA for Mam Cooler.

Pre-market Notification Details

Device IDK093266
510k NumberK093266
Device Name:MAM COOLER
ClassificationRing, Teething, Fluid-filled
Applicant MAM INTERNATIONAL AG CORPORATE PARK DRIVE 106 White Plains,  NY  10604
ContactMichael Tedesco
CorrespondentMichael Tedesco
MAM INTERNATIONAL AG CORPORATE PARK DRIVE 106 White Plains,  NY  10604
Product CodeKKO  
CFR Regulation Number872.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-19
Decision Date2010-07-27

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