Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump

Pump, Breast, Powered

Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd

The following data is part of a premarket notification filed by Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd with the FDA for Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump.

Pre-market Notification Details

Device IDK182749
510k NumberK182749
Device Name:Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
ClassificationPump, Breast, Powered
Applicant Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd Sti. 10006 Sok. No: 64 AOSB Cigli,  TR 35620
ContactLindsay Ewers
CorrespondentLindsay Ewers
Lansinoh Laboratories 333 N Fairfax St Ste 400 Alexandria,  VA  22314
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-28
Decision Date2019-06-12
Summary:summary

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