Cleared Traditional

C-SECTION TRAY

K912075 · Medical Device Inspection Co., Inc. · Obstetrics & Gynecology
Apr 1992
Decision
333d
Days
Class 2
Risk

About This 510(k) Submission

K912075 is an FDA 510(k) clearance for the C-SECTION TRAY, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on April 7, 1992, 333 days after receiving the submission on May 10, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K912075 FDA.gov
FDA Decision Cleared SESK
Date Received May 10, 1991
Decision Date April 07, 1992
Days to Decision 333 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code KNA — Instrument, Manual, Specialized Obstetric-gynecologic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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