LANSINOH POWERED ELECTRIC BREAST PUMP

Pump, Breast, Powered

LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN

The following data is part of a premarket notification filed by Lansinoh Laboratories Saglik Gerecleri Tasarim San with the FDA for Lansinoh Powered Electric Breast Pump.

Pre-market Notification Details

Device IDK122474
510k NumberK122474
Device Name:LANSINOH POWERED ELECTRIC BREAST PUMP
ClassificationPump, Breast, Powered
Applicant LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN 13417 QUIVAS ST Westminster,  CO  80234
ContactCalley Herzog
CorrespondentCalley Herzog
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN 13417 QUIVAS ST Westminster,  CO  80234
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-14
Decision Date2012-12-28
Summary:summary

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