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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 K854077
Device Name MIX EVAC II
Applicant
STRYKER CORP.
420 ALCOTT ST.
KALAMAZOO,  MI  49001
Applicant Contact HARMON H WOODWORTH
Correspondent
STRYKER CORP.
420 ALCOTT ST.
KALAMAZOO,  MI  49001
Correspondent Contact HARMON H WOODWORTH
Regulation Number888.4210
Classification Product Code
JDZ  
Date Received10/07/1985
Decision Date 01/31/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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