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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystourethroscope
510(k) Number K934649
Device Name GALILEO ENDOSCOPES
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 Number876.1500
Classification Product Code
FBO  
Date Received09/29/1993
Decision Date 10/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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