Saffron Fixation System

Fixation, Non-absorbable Or Absorbable, For Pelvic Use

Coloplast A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Saffron Fixation System.

Pre-market Notification Details

Device IDK220420
510k NumberK220420
Device Name:Saffron Fixation System
ClassificationFixation, Non-absorbable Or Absorbable, For Pelvic Use
Applicant Coloplast A/S 1601 West River Road North Minneapolis,  MN  55411
ContactGayatri Ghadge
CorrespondentGayatri Ghadge
Coloplast A/S 1601 West River Road North Minneapolis,  MN  55411
Product CodePBQ  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-14
Decision Date2022-06-10

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