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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
Recalls CDRH Recalls
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