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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Cement, For Clinical Use
510(k) Number K912190
Device Name STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
Applicant
Stryker Corp.
P.O. Box 4085
Kalamazoo,  MI  49003 -4085
Applicant Contact HARMON H WOODWORTH
Correspondent
Stryker Corp.
P.O. Box 4085
Kalamazoo,  MI  49003 -4085
Correspondent Contact HARMON H WOODWORTH
Regulation Number888.4210
Classification Product Code
JDZ  
Date Received05/17/1991
Decision Date 08/29/1991
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
Recalls CDRH Recalls
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