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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Fiber Optic
510(k) Number K843900
Device Name FOCUSCOPE UNIVERSAL SYSTEM
Applicant
Medical Diagnostics, Ca.
2004 Kiser Dr.
Valrico,  FL  33594
Applicant Contact PAUL BUTLER
Correspondent
Medical Diagnostics, Ca.
2004 Kiser Dr.
Valrico,  FL  33594
Correspondent Contact PAUL BUTLER
Regulation Number876.1500
Classification Product Code
GDB  
Date Received10/03/1984
Decision Date 12/06/1984
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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