KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)

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 Micro Osteosythesis System(1.5mm).

Pre-market Notification Details

Device IDK944565
510k NumberK944565
Device Name:KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)
ClassificationPlate, Bone
Applicant KLS-MARTIN L.P. REGULATORY CONSULTANT 2550 M STREET, N.W. Washington,  DC  20037
ContactLouise N Howe
CorrespondentLouise N Howe
KLS-MARTIN L.P. REGULATORY CONSULTANT 2550 M STREET, N.W. Washington,  DC  20037
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-16
Decision Date1994-10-18

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