COALESCENT U-CLIP- AND ACCESSORIES

Suture, Nonabsorbable, Nitinol

COALESCENT SURGICAL

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

Pre-market Notification Details

Device IDK023125
510k NumberK023125
Device Name:COALESCENT U-CLIP- AND ACCESSORIES
ClassificationSuture, Nonabsorbable, Nitinol
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 CodeNJU  
CFR Regulation Number878.4495 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-19
Decision Date2002-12-18
Summary:summary

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