Instrument Clamps Electromagnetic

Ear, Nose, And Throat Stereotaxic Instrument

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Instrument Clamps Electromagnetic.

Pre-market Notification Details

Device IDK202609
510k NumberK202609
Device Name:Instrument Clamps Electromagnetic
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Stryker Corporation Boetzinger Strasse 41 Freiburg,  DE D-79111
ContactMaya Schiel
CorrespondentMaya Schiel
Stryker Corporation Boetzinger Strasse 41 Freiburg,  DE D-79111
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-09
Decision Date2020-10-09

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