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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 K934707
Device Name GALILEO ARTHROSCOPES
Applicant
Galileo Electro-Optics Corp.
P.O. Box 550
Galileo Park
Sturbridge,  MA  01566
Applicant Contact ROBERT D SALVUCCI
Correspondent
Galileo Electro-Optics Corp.
P.O. Box 550
Galileo Park
Sturbridge,  MA  01566
Correspondent Contact ROBERT D SALVUCCI
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/30/1993
Decision Date 10/07/1994
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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