Wishbone HA

Bone Grafting Material, Animal Source

Wishbone SA

The following data is part of a premarket notification filed by Wishbone Sa with the FDA for Wishbone Ha.

Pre-market Notification Details

Device IDK211551
510k NumberK211551
Device Name:Wishbone HA
ClassificationBone Grafting Material, Animal Source
Applicant Wishbone SA 1, Rue De 1'Expansion Flemalle,  BE 4400
ContactEmilie Dory
CorrespondentEmilie Dory
Wishbone SA 1, Rue De 1'Expansion Flemalle,  BE 4400
Product CodeNPM  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-19
Decision Date2021-08-20

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