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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
Recalls CDRH Recalls
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