Cleared Traditional

VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT

K892693 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology
May 1989
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K892693 is an FDA 510(k) clearance for the VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT, a Instrument, Manual, General Obstetric-gynecologic (Class I — General Controls, product code KOH), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 11, 1989, 28 days after receiving the submission on April 13, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4520.

Submission Details

510(k) Number K892693 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1989
Decision Date May 11, 1989
Days to Decision 28 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code KOH — Instrument, Manual, General Obstetric-gynecologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.4520

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