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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 K904797
Device Name SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)
Applicant
SURGITEK
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Applicant Contact STEVE APERAVICH
Correspondent
SURGITEK
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Correspondent Contact STEVE APERAVICH
Regulation Number876.1500
Classification Product Code
FBO  
Date Received10/23/1990
Decision Date 03/05/1991
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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