Graftgun Universal Graft Delivery System

Syringe, Piston

Surgentec, LLC

The following data is part of a premarket notification filed by Surgentec, Llc with the FDA for Graftgun Universal Graft Delivery System.

Pre-market Notification Details

Device IDK170675
510k NumberK170675
Device Name:Graftgun Universal Graft Delivery System
ClassificationSyringe, Piston
Applicant Surgentec, LLC 7601 N Federal Highway # 150B Boca Raton,  FL  33487
ContactTravis Greenhalgh
CorrespondentTravis Greenhalgh
Surgentec, LLC 7601 N Federal Highway # 150B Boca Raton,  FL  33487
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-06
Decision Date2017-07-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00810131880545 K170675 000

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