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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 K042780
Device Name NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
Applicant
PROSURG, INC.
2193 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
PROSURG, INC.
2193 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received10/06/2004
Decision Date 02/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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