KNIFE BLADE TIP

Knife, Ear

TREACE MEDICAL, INC.

The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Knife Blade Tip.

Pre-market Notification Details

Device IDK823911
510k NumberK823911
Device Name:KNIFE BLADE TIP
ClassificationKnife, Ear
Applicant TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJYO  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-28
Decision Date1983-01-21

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