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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Rigid
510(k) Number K921918
Device Name FIBER OPTIC ENDOSCOPE
Applicant
Electro Fiberoptics Corp.
56 Hudson St.
Northborough,  MA  01532
Applicant Contact KENNETH J DURBIN
Correspondent
Electro Fiberoptics Corp.
56 Hudson St.
Northborough,  MA  01532
Correspondent Contact KENNETH J DURBIN
Regulation Number876.1500
Classification Product Code
GCM  
Subsequent Product Code
GDB  
Date Received04/23/1992
Decision Date 08/17/1993
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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