KLS Martin Neuro Rongeurs

Rongeur, Manual

KLS-MARTIN L.P.

The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin Neuro Rongeurs.

Pre-market Notification Details

Device IDK210741
510k NumberK210741
Device Name:KLS Martin Neuro Rongeurs
ClassificationRongeur, Manual
Applicant KLS-MARTIN L.P. 11201 Saint Johns Industrial Parkway South Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentSusan Leander
KLS-MARTIN L.P. 11201 Saint Johns Industrial Parkway South Jacksonville,  FL  32246
Product CodeHAE  
CFR Regulation Number882.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-12
Decision Date2022-06-03

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