BALLOON UTERINE STENT— 510(k) K952527

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K952527 for BALLOON UTERINE STENT, Substantially Equivalent on 1996-01-02. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1995-06-01
Decision date: 1996-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-1005002006-10-27

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