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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 K926287
Device Name EXERCISE BICYCLE
Applicant
HENLEY INTL.
104 INDUSTRIAL BLVD.,
SUGAR LAND,  TX  77470
Applicant Contact ERNEST J HENLEY
Correspondent
HENLEY INTL.
104 INDUSTRIAL BLVD.,
SUGAR LAND,  TX  77470
Correspondent Contact ERNEST J HENLEY
Regulation Number890.5360
Classification Product Code
ISD  
Date Received12/14/1992
Decision Date 03/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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