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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Nonpowered
510(k) Number K810441
Device Name UNIVERSAL GONIMETER
Applicant
FRED SAMMONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FRED SAMMONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.1520
Classification Product Code
KQW  
Date Received02/19/1981
Decision Date 02/27/1981
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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