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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Ac-Powered
510(k) Number K884003
Device Name GONIOMETER AND BIOMEDICAL RECORDER SYSTEM
Applicant
Penny & Giles Blackwood , Ltd.
Blackwood Gwent
Np2 Syd, United Kingdom
England,  GB
Applicant Contact DR. I THOMAS
Correspondent
Penny & Giles Blackwood , Ltd.
Blackwood Gwent
Np2 Syd, United Kingdom
England,  GB
Correspondent Contact DR. I THOMAS
Regulation Number888.1500
Classification Product Code
KQX  
Date Received09/21/1988
Decision Date 12/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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