NOVASYS TRANSURETHRAL RF SYSTEM— 510(k) K042132

Name: FDA 510(k) clearance K042132
Creator: U.S. Food and Drug Administration
Published: 2004-12-21

Substantially Equivalent

Novasys Medical, Inc.

FDA 510(k) clearance K042132 for NOVASYS TRANSURETHRAL RF SYSTEM, Substantially Equivalent on 2004-12-21. Applicant: Novasys Medical, Inc.. Device class: 2.

Clearance details

Applicant: Novasys Medical, Inc.
Product code: Code NVJ
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2004-08-09
Decision date: 2004-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, CA, US

Download summary PDF View on FDA.gov ↗

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