GENXCATHETER— 510(k) K963031

Substantially Equivalent

Genx Intl., Inc.

FDA 510(k) clearance K963031 for GENXCATHETER, Substantially Equivalent on 1996-10-21. Applicant: Genx Intl., Inc.. Device class: 2.

Clearance details

Applicant
Genx Intl., Inc.
Product code
Code MFD
Device class
Class 2
Regulation
21 CFR 884.5250
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Madison, CT, US
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