SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)— 510(k) K991235

Name: FDA 510(k) clearance K991235
Creator: U.S. Food and Drug Administration
Published: 1999-07-08

Substantially Equivalent

Ludlow Technical Products

FDA 510(k) clearance K991235 for SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC), Substantially Equivalent on 1999-07-08. Applicant: Ludlow Technical Products. Device class: 2.

Clearance details

Applicant: Ludlow Technical Products
Product code: Code KXO
Device class: Class 2
Regulation: 21 CFR 884.2700
Advisory panel: Obstetrics/Gynecology
Date received: 1999-04-12
Decision date: 1999-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicopee, MA, US

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