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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K894558
Device Name MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET
Applicant
Optik
2131espey Ct.
Suite 7
Criftib,  MD  21114
Applicant Contact WILLIAM M MACFIE
Correspondent
Optik
2131espey Ct.
Suite 7
Criftib,  MD  21114
Correspondent Contact WILLIAM M MACFIE
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/20/1989
Decision Date 08/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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