Cleared Traditional

C-SECTION PACK

K921730 · Medikmark, Inc. · Obstetrics & Gynecology
Jun 1994
Decision
796d
Days
Class 1
Risk

About This 510(k) Submission

K921730 is an FDA 510(k) clearance for the C-SECTION PACK, a Instrument, Manual, General Obstetric-gynecologic (Class I — General Controls, product code KOH), submitted by Medikmark, Inc. (Chicago, US). The FDA issued a Cleared decision on June 15, 1994, 796 days after receiving the submission on April 10, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4520.

Submission Details

510(k) Number K921730 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1992
Decision Date June 15, 1994
Days to Decision 796 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

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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