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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 K093677
FOIA Releasable 510(k) K093677
Device Name STRYKER ARTHROSCOPE
Applicant
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact SHIBIR DESAI
Correspondent
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact SHIBIR DESAI
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/27/2009
Decision Date 03/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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