Turbett Surgical Container

Wrap, Sterilization

TURBETT SURGICAL LLC

The following data is part of a premarket notification filed by Turbett Surgical Llc with the FDA for Turbett Surgical Container.

Pre-market Notification Details

Device IDK153025
510k NumberK153025
Device Name:Turbett Surgical Container
ClassificationWrap, Sterilization
Applicant TURBETT SURGICAL LLC 125 TECH PARK DRIVE SUITE 2108 Rochester,  NY  14623
ContactRob Turbett
CorrespondentDavid Furr
FDC Services 8708 CAPEHART COVE Austin,  TX  78733
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-16
Decision Date2016-01-14
Summary:summary

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