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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K943323
Device Name STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES
Applicant
Stryker Corp.
4100 E Milham Ave.
Portage,  MI  49002 -9704
Applicant Contact TAMMY LOUNDS
Correspondent
Stryker Corp.
4100 E Milham Ave.
Portage,  MI  49002 -9704
Correspondent Contact TAMMY LOUNDS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/11/1994
Decision Date 11/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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