STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH

Orthopedic Manual Surgical Instrument

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Femoral Canal Brush, Acetabular Brush.

Pre-market Notification Details

Device IDK941605
510k NumberK941605
Device Name:STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
ClassificationOrthopedic Manual Surgical Instrument
Applicant STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo,  MI  49001
ContactCathy L Cadwallader
CorrespondentCathy L Cadwallader
STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo,  MI  49001
Product CodeLXH  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-01
Decision Date1994-08-05

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