Ergonomic Handle

Laparoscope, General & Plastic Surgery

Symmetry Surgical Inc.

The following data is part of a premarket notification filed by Symmetry Surgical Inc. with the FDA for Ergonomic Handle.

Pre-market Notification Details

Device IDK173272
510k NumberK173272
Device Name:Ergonomic Handle
ClassificationLaparoscope, General & Plastic Surgery
Applicant Symmetry Surgical Inc. 3034 Owen Drive Antioch,  TN  37013
ContactChristopher Smith
CorrespondentChristopher Smith
Symmetry Surgical Inc. 3034 Owen Drive Antioch,  TN  37013
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-12
Decision Date2018-02-09
Summary:summary

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