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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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