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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 K954016
Device Name VIDEOSCOPE W/IRRIGATION SHEATH
Applicant
T. Korossurgical Instruments Corp.
610 Flinn Ave.
Moorepark,  CA  93021
Applicant Contact GABRIEL KOROS
Correspondent
T. Korossurgical Instruments Corp.
610 Flinn Ave.
Moorepark,  CA  93021
Correspondent Contact GABRIEL KOROS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/25/1995
Decision Date 01/25/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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