BABYLANCE HEEL INCISION DEVICE

Lancet, Blood

MEDIPURPOSE PTE. LTD.

The following data is part of a premarket notification filed by Medipurpose Pte. Ltd. with the FDA for Babylance Heel Incision Device.

Pre-market Notification Details

Device IDK130132
510k NumberK130132
Device Name:BABYLANCE HEEL INCISION DEVICE
ClassificationLancet, Blood
Applicant MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta,  GA  30004
ContactJulie Stephens
CorrespondentJulie Stephens
MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta,  GA  30004
Product CodeFMK  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-18
Decision Date2013-02-11
Summary:summary

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