SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)— 510(k) K964279

Name: FDA 510(k) clearance K964279
Creator: U.S. Food and Drug Administration
Published: 1997-01-22

Substantially Equivalent

Graphic Controls Corp.

FDA 510(k) clearance K964279 for SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC), Substantially Equivalent on 1997-01-22. Applicant: Graphic Controls Corp.. Device class: 2.

Clearance details

Applicant: Graphic Controls Corp.
Product code: Code KXO
Device class: Class 2
Regulation: 21 CFR 884.2700
Advisory panel: Obstetrics/Gynecology
Date received: 1996-10-28
Decision date: 1997-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buafflo, NY, US

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