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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 K935221
Device Name STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS
Applicant
Stryker Endoscopy
210 Baypointe Pkwy.
San Jose,  CA  95134
Applicant Contact TOM KELLY
Correspondent
Stryker Endoscopy
210 Baypointe Pkwy.
San Jose,  CA  95134
Correspondent Contact TOM KELLY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/01/1993
Decision Date 04/28/1994
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
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