SIMPLYGO BREAST PUMP

Pump, Breast, Powered

EVENFLO COMPANY, INC.

The following data is part of a premarket notification filed by Evenflo Company, Inc. with the FDA for Simplygo Breast Pump.

Pre-market Notification Details

Device IDK102600
510k NumberK102600
Device Name:SIMPLYGO BREAST PUMP
ClassificationPump, Breast, Powered
Applicant EVENFLO COMPANY, INC. 225 BYERS RD. Miamisburg,  OH  45342
ContactAmy Neff
CorrespondentAmy Neff
EVENFLO COMPANY, INC. 225 BYERS RD. Miamisburg,  OH  45342
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-10
Decision Date2010-12-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849409000040 K102600 000
00849409000033 K102600 000

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