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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Measuring
510(k) Number K934238
Device Name MULE
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 Number890.5360
Classification Product Code
ISD  
Date Received08/30/1993
Decision Date 10/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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