BIOGEL PL MICRO SURGICAL GLOVE

Surgeon's Gloves

MOLNLYCKE HEALTH CARE, US LLC

The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for Biogel Pl Micro Surgical Glove.

Pre-market Notification Details

Device IDK141719
510k NumberK141719
Device Name:BIOGEL PL MICRO SURGICAL GLOVE
ClassificationSurgeon's Gloves
Applicant MOLNLYCKE HEALTH CARE, US LLC 5550 PEACHTREE PARKWAY, SUITE 500 Norcross,  GA  30092
ContactCurtis Truesdale
CorrespondentCurtis Truesdale
MOLNLYCKE HEALTH CARE, US LLC 5550 PEACHTREE PARKWAY, SUITE 500 Norcross,  GA  30092
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-25
Decision Date2014-09-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07323190070787 K141719 000
07323190070732 K141719 000
07323190070947 K141719 000
07323190070701 K141719 000
07323190070985 K141719 000
07323190070862 K141719 000
07323190070909 K141719 000
07323190070664 K141719 000

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