STRYKER HUMMER II MICRODEBRIDER SYSTEM

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

Stryker Endoscopy

The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Hummer Ii Microdebrider System.

Pre-market Notification Details

Device IDK972584
510k NumberK972584
Device Name:STRYKER HUMMER II MICRODEBRIDER SYSTEM
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant Stryker Endoscopy 2590 WALSH AVE. Santa Clara,  CA  95051 -4085
ContactCarlos Gonzalez
CorrespondentCarlos Gonzalez
Stryker Endoscopy 2590 WALSH AVE. Santa Clara,  CA  95051 -4085
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-10
Decision Date1997-10-01
Summary:summary

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