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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical radiofrequency system, stress urinary incontinence, female, transvaginal or laparoscopic, pelvic tissue
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
Applicant Contact ALAN CURTIS
Correspondent
SURX, INC.
6900 KOLL CENTER PKWY., #417
PLEASANTON,  CA  94566
Correspondent Contact ALAN CURTIS
Regulation Number878.4400
Classification Product Code
MUK  
Date Received04/19/2001
Decision Date 01/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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