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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 K870654
Device Name EFER ARTHROSCOPE
Applicant
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Applicant Contact DARIENNE MOYER
Correspondent
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Correspondent Contact DARIENNE MOYER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/13/1987
Decision Date 05/14/1987
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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