MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES

Clip, Implantable

COALESCENT SURGICAL

The following data is part of a premarket notification filed by Coalescent Surgical with the FDA for Modification To Coalescent Surgical U-clip And Accessories.

Pre-market Notification Details

Device IDK031623
510k NumberK031623
Device Name:MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
ClassificationClip, Implantable
Applicant COALESCENT SURGICAL 559 EAST WEDDELL DR. Sunnyvale,  CA  94089
ContactMichael A Daniel
CorrespondentMichael A Daniel
COALESCENT SURGICAL 559 EAST WEDDELL DR. Sunnyvale,  CA  94089
Product CodeFZP  
Subsequent Product CodeNCA
Subsequent Product CodeNJU
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-23
Decision Date2003-07-03
Summary:summary

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