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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name applicator, transurethral, radio frequency, for stress urinary incontinence in women
510(k) Number K042132
Device Name NOVASYS TRANSURETHRAL RF SYSTEM
Applicant
NOVASYS MEDICAL, INC.
39684 EUREKA DR.
NEWARK,  CA  94560
Applicant Contact DEBRA REISENTHEL
Correspondent
NOVASYS MEDICAL, INC.
39684 EUREKA DR.
NEWARK,  CA  94560
Correspondent Contact DEBRA REISENTHEL
Regulation Number878.4400
Classification Product Code
NVJ  
Date Received08/09/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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