Dannik Titanium Ligation Clip

Clip, Implantable

Dannik

The following data is part of a premarket notification filed by Dannik with the FDA for Dannik Titanium Ligation Clip.

Pre-market Notification Details

Device IDK192711
510k NumberK192711
Device Name:Dannik Titanium Ligation Clip
ClassificationClip, Implantable
Applicant Dannik 941 W Morse Blvd. Suite 100 Winter Park,  FL  32789
ContactOlga Haberlad
CorrespondentOlga Haberlad
Dannik 941 W Morse Blvd. Suite 100 Winter Park,  FL  32789
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-27
Decision Date2019-12-20

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