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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 K944210
Device Name ARTHROSCOPE ACCESSORIES
Applicant
Stryker Endoscopy
210 Baypointe Pkwy.
San Jose,  CA  95134
Applicant Contact KENNETH M ISSER
Correspondent
Stryker Endoscopy
210 Baypointe Pkwy.
San Jose,  CA  95134
Correspondent Contact KENNETH M ISSER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/29/1994
Decision Date 02/14/1995
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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