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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K941605
Device Name STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
Applicant
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact CATHY L CADWALLADER
Correspondent
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact CATHY L CADWALLADER
Regulation Number888.4540
Classification Product Code
LXH  
Date Received04/01/1994
Decision Date 08/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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