KLS Martin Individual Patient Solutions

Plate, Bone

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 Individual Patient Solutions.

Pre-market Notification Details

Device IDK191028
501k NumberK191028
Device Name:KLS Martin Individual Patient Solutions
ClassificationPlate, Bone
Applicant KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentKatie Rutland
KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville,  FL  32246
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-18
Decision Date2019-11-22

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