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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
510(k) Number K961970
Device Name COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
Applicant
STRYKER CORP.
2725 FAIRFIELD RD.
KALAMAZOO,  MI  49002
Applicant Contact DIANE DAVIS
Correspondent
STRYKER CORP.
2725 FAIRFIELD RD.
KALAMAZOO,  MI  49002
Correspondent Contact DIANE DAVIS
Regulation Number878.4820
Classification Product Code
HWE  
Date Received05/20/1996
Decision Date 07/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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