STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

Driver, Wire, And Bone Drill, Manual

STRYKER INSTRUMENTS

The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Consolidated Operating Room Equipment (core) System.

Pre-market Notification Details

Device IDK040369
510k NumberK040369
Device Name:STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
ClassificationDriver, Wire, And Bone Drill, Manual
Applicant STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
ContactJean W Sheppard
CorrespondentJean W Sheppard
STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
Product CodeDZJ  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-13
Decision Date2004-04-01
Summary:summary

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