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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, ac-powered and accessories
510(k) Number K771918
Device Name FIBEO OPTICS ILLUM. SYSTEM
Applicant
PROPPER MFG. CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PROPPER MFG. CO., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1500
Classification Product Code
GCP  
Date Received10/12/1977
Decision Date 10/20/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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