BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT

Surgeon's Gloves

MOLNLYCKE HEALTHCARE, US LLC

The following data is part of a premarket notification filed by Molnlycke Healthcare, Us Llc with the FDA for Biogel Orthopaedic Surgical Glove With Non-pryogenic Statement.

Pre-market Notification Details

Device IDK071465
510k NumberK071465
Device Name:BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
ClassificationSurgeon's Gloves
Applicant MOLNLYCKE HEALTHCARE, US LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross,  GA  30092
ContactSteven Dowdley
CorrespondentSteven Dowdley
MOLNLYCKE HEALTHCARE, 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 Received2007-05-29
Decision Date2007-09-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060097934171 K071465 000
05060097934096 K071465 000
05060097934157 K071465 000
05060097934072 K071465 000
05060097934133 K071465 000
05060097934126 K071465 000
05060097934041 K071465 000

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