ERCH ARCH BAR, MODEL 38-690-00

Lock, Wire, And Ligature, Intraoral

KLS-MARTIN L.P.

The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Erch Arch Bar, Model 38-690-00.

Pre-market Notification Details

Device IDK061271
510k NumberK061271
Device Name:ERCH ARCH BAR, MODEL 38-690-00
ClassificationLock, Wire, And Ligature, Intraoral
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 CodeDYX  
CFR Regulation Number872.4600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-05
Decision Date2006-06-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H834PM6700 K061271 000
M274P6700 K061271 000

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