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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 K900609
Device Name SHEPPERD STRAIGHT AND CURVED NEEDLES
Applicant
Downs Surgical , Ltd.
Pkwy. Close,Pkwy.
Industrial Estate
Sheffield S9 4wj,  GB
Applicant Contact J NEWSON
Correspondent
Downs Surgical , Ltd.
Pkwy. Close,Pkwy.
Industrial Estate
Sheffield S9 4wj,  GB
Correspondent Contact J NEWSON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/08/1990
Decision Date 10/22/1990
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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