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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Ear, Nose And Throat
510(k) Number K060750
Device Name STRYKER INJECTABLE CEMENT
Applicant
Stryker Cmf
750 Trade Centre Way
Kalamazoo,  MI  49001
Applicant Contact WADE T RUTKOSKIE
Correspondent
Stryker Cmf
750 Trade Centre Way
Kalamazoo,  MI  49001
Correspondent Contact WADE T RUTKOSKIE
Regulation Number872.3275
Classification Product Code
NEA  
Date Received03/21/2006
Decision Date 04/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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