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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrosurgical, active, urological
510(k) Number K981256
Device Name ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
Applicant
XIMED/PROSURE/INJECTX
2193 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
XIMED/PROSURE/INJECTX
2193 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
FDC  
Date Received04/02/1998
Decision Date 05/12/1998
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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