PATIENT CONTOURED MESH-PEEK (PCM-P)

Plate, Cranioplasty, Preformed, Non-alterable

KLS-MARTIN L.P.

The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Patient Contoured Mesh-peek (pcm-p).

Pre-market Notification Details

Device IDK072707
510k NumberK072707
Device Name:PATIENT CONTOURED MESH-PEEK (PCM-P)
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
Applicant KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentJennifer Damato
KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville,  FL  32246
Product CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-25
Decision Date2007-12-19
Summary:summary

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