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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 K810640
Device Name POLARISED LIGHT GRONIOMETER
Applicant
CAIRCO LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CAIRCO LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.1500
Classification Product Code
KQX  
Date Received03/10/1981
Decision Date 04/17/1981
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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