Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro

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 Skinsense Indicator Underglove, Biogel Pi Ultratouch, Biogel Pi Indicator Underglove, Biogel Pi, Biogel Pi Micro.

Pre-market Notification Details

Device IDK193573
510k NumberK193573
Device Name:Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
ClassificationSurgeon's Gloves
Applicant Molnlycke Health Care US LLC. 5550 Peachtree Parkway, Suite 500 Norcross,  GA  30092
ContactCalen Souther
CorrespondentCalen Souther
Molnlycke Health Care US LLC. 5550 Peachtree Parkway, Suite 500 Norcross,  GA  30092
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-04-10

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