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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Surgical With Orthopedic Accessories, Ac-Powered
510(k) Number K953071
Device Name STRYKER COMMAND2 OFFICE CONSOLE
Applicant
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact TAMMY LOUNDS
Correspondent
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact TAMMY LOUNDS
Regulation Number878.4960
Classification Product Code
JEA  
Date Received06/30/1995
Decision Date 08/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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