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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K954690
Device Name STRYKER ORAL MAX SYSTEM
Applicant
Stryker Corp.
2725 Fairfield Rd.
P.O. Box 4085
Kalamazoo,  MI  49003 -4085
Applicant Contact TAMMY LOUNDS
Correspondent
Stryker Corp.
2725 Fairfield Rd.
P.O. Box 4085
Kalamazoo,  MI  49003 -4085
Correspondent Contact TAMMY LOUNDS
Regulation Number872.4120
Classification Product Code
DZI  
Date Received10/11/1995
Decision Date 08/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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