Cleared Traditional

LABOR DELIVERY TRAY

K912054 · Medical Device Inspection Co., Inc. · Obstetrics & Gynecology
Jan 1992
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K912054 is an FDA 510(k) clearance for the LABOR DELIVERY TRAY, a Clamp, Umbilical (Class II — Special Controls, product code HFW), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on January 21, 1992, 257 days after receiving the submission on May 9, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K912054 FDA.gov
FDA Decision Cleared SESK
Date Received May 09, 1991
Decision Date January 21, 1992
Days to Decision 257 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HFW — Clamp, Umbilical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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