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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Pneumatic Powered
510(k) Number K863447
Device Name STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM 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 Number878.4820
Classification Product Code
GET  
Subsequent Product Code
DWG  
Date Received09/08/1986
Decision Date 09/29/1986
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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