Neptune E-SEP Smoke Evacuation Pencil

Electrosurgical, Cutting & Coagulation & Accessories

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Neptune E-sep Smoke Evacuation Pencil.

Pre-market Notification Details

Device IDK160693
510k NumberK160693
Device Name:Neptune E-SEP Smoke Evacuation Pencil
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant STRYKER CORPORATION 4100 E. MILHAM AVENUE Kalamazoo,  MI  49001
ContactMairead Twomey
CorrespondentMairead Twomey
STRYKER CORPORATION 4100 E. MILHAM AVENUE Kalamazoo,  MI  49001
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-14
Decision Date2016-04-13
Summary:summary

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