3D GraftRasp System

Syringe, Piston

SurGenTec

The following data is part of a premarket notification filed by Surgentec with the FDA for 3d Graftrasp System.

Pre-market Notification Details

Device IDK201900
510k NumberK201900
Device Name:3D GraftRasp System
ClassificationSyringe, Piston
Applicant SurGenTec 911 Clint Moore Rd Boca Raton,  FL  33847
ContactAndrew Shoup
CorrespondentAndrew Shoup
SurGenTec 911 Clint Moore Rd Boca Raton,  FL  33847
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-08
Decision Date2020-09-03

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