FDA 510(k) Applications Submitted by NOVASYS MEDICAL, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K042132 08/09/2004 NOVASYS TRANSURETHRAL RF SYSTEM NOVASYS MEDICAL, INC.
K001150 04/10/2000 ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE NOVASYS MEDICAL, INC.
K001151 04/10/2000 ELECTROSURGICAL ELECTRODE FAMILY NOVASYS MEDICAL, INC.
K001328 04/26/2000 INTRODUCER SHEATH NOVASYS MEDICAL, INC.
K013730 11/09/2001 ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES NOVASYS MEDICAL, INC.


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