SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)— 510(k) K974730

Name: FDA 510(k) clearance K974730
Creator: U.S. Food and Drug Administration
Published: 1998-07-14

Substantially Equivalent

Graphic Controls Corp.

FDA 510(k) clearance K974730 for SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC), Substantially Equivalent on 1998-07-14. 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: 1997-12-18
Decision date: 1998-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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K961290 — IUP - TIP TRANS, IUP - PROXI TRANS1996-10-15
K950498 — LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER1995-07-24

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K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE1997-08-27
K964387 — POINT OF USE II SHARPS-A-GATOR1997-03-27

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