FDA 510(k) Application Details - K981256

Device Classification Name Electrode, Electrosurgical, Active, Urological

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510(K) Number K981256
Device Name Electrode, Electrosurgical, Active, Urological
Applicant XIMED/PROSURE/INJECTX
2193 TRADE ZONE BLVD.
SAN JOSE, CA 95131 US
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Contact ASHVIN DESAI
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Regulation Number 876.4300

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Classification Product Code FAS
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Date Received 04/02/1998
Decision Date 05/12/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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