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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dynamometer, Nonpowered
510(k) Number K894557
Device Name LIGHTSCOPE SET
Applicant
Optik
2131espey Ct.
Suite 7
Criftib,  MD  21114
Applicant Contact WILLIAMS M MACFIE
Correspondent
Optik
2131espey Ct.
Suite 7
Criftib,  MD  21114
Correspondent Contact WILLIAMS M MACFIE
Regulation Number888.1250
Classification Product Code
HRW  
Date Received07/20/1989
Decision Date 08/07/1989
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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