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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 K924416
Device Name BOOST, MICE, GAMESYS.
Applicant
PENNY AND GILES BIOMETRICS LTD.
BLACKWOOD GWENT
NP22YD UNITED KINGDOM
ENGLAND,  GB
Applicant Contact IAN THOMAS
Correspondent
PENNY AND GILES BIOMETRICS LTD.
BLACKWOOD GWENT
NP22YD UNITED KINGDOM
ENGLAND,  GB
Correspondent Contact IAN THOMAS
Regulation Number888.1500
Classification Product Code
KQX  
Date Received08/31/1992
Decision Date 06/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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