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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K945262
Device Name OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
Applicant
OPTUS, INC.
1200 SOUTH PARKER RD.
DENVER,  CO  80231
Applicant Contact PETER DUFFY
Correspondent
OPTUS, INC.
1200 SOUTH PARKER RD.
DENVER,  CO  80231
Correspondent Contact PETER DUFFY
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received10/28/1994
Decision Date 05/26/1995
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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