FDA 510(k) Application Details - K011190

Device Classification Name

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510(K) Number K011190
Device Name SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
Applicant SURX, INC.
6900 KOLL CENTER PKWY., #417
PLEASANTON, CA 94566 US
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Contact ALAN CURTIS
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Regulation Number

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Classification Product Code MUK
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Date Received 04/19/2001
Decision Date 01/08/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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