Turbett Instrument Pod

Wrap, Sterilization

Turbett Surgical Inc.

The following data is part of a premarket notification filed by Turbett Surgical Inc. with the FDA for Turbett Instrument Pod.

Pre-market Notification Details

Device IDK202593
510k NumberK202593
Device Name:Turbett Instrument Pod
ClassificationWrap, Sterilization
Applicant Turbett Surgical Inc. 125 Tech Park Drive Rochester,  NY  14625
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 Received2020-09-08
Decision Date2021-05-19

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