URETHRA-BRUSH— 510(k) K942144

Substantially Equivalent

Rovers Diagnostic Devices

FDA 510(k) clearance K942144 for URETHRA-BRUSH, Substantially Equivalent on 1994-06-27. Applicant: Rovers Diagnostic Devices. Device class: 2.

Clearance details

Applicant: Rovers Diagnostic Devices
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-05-03
Decision date: 1994-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boonton, NJ, US

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More clearances from Rovers Diagnostic Devices

K941472 — CERVEX-BRUSH PAP KIT1995-02-28
K942843 — CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY1994-12-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.