Cleared Traditional

TWIN BALLOON INJECTOR

K902975 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology
Sep 1990
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K902975 is an FDA 510(k) clearance for the TWIN BALLOON INJECTOR, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on September 26, 1990, 82 days after receiving the submission on July 6, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K902975 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1990
Decision Date September 26, 1990
Days to Decision 82 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code LKF — Cannula, Manipulator/injector, Uterine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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