U-CLIP UNI-FIRE, MODEL M65

Clip, Implantable

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for U-clip Uni-fire, Model M65.

Pre-market Notification Details

Device IDK081082
510k NumberK081082
Device Name:U-CLIP UNI-FIRE, MODEL M65
ClassificationClip, Implantable
Applicant MEDTRONIC INC. 3051 S. NEWCOMBE WAY Lakewood,  CO  80227
ContactDavid D Cox
CorrespondentDavid D Cox
MEDTRONIC INC. 3051 S. NEWCOMBE WAY Lakewood,  CO  80227
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-16
Decision Date2008-05-07
Summary:summary

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