Cleared Traditional

WOMEN AND INFANT'S DELIVERY PACK

K912869 · Welcon, Inc. · Obstetrics & Gynecology
Dec 1991
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K912869 is an FDA 510(k) clearance for the WOMEN AND INFANT'S DELIVERY PACK, a Clamp, Umbilical (Class II — Special Controls, product code HFW), submitted by Welcon, Inc. (Providence, US). The FDA issued a Cleared decision on December 4, 1991, 159 days after receiving the submission on June 28, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K912869 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1991
Decision Date December 04, 1991
Days to Decision 159 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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