Cleared Traditional

CARAPACE LABOR AND DELIVERY SETS

K931722 · Carapace, Inc. · Obstetrics & Gynecology

Mar 1994

Decision

350d

Days

Class 2

Risk

About This 510(k) Submission

K931722 is an FDA 510(k) clearance for the CARAPACE LABOR AND DELIVERY SETS, a Labor And Delivery Kit (Class II — Special Controls, product code MLS), submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on March 23, 1994, 350 days after receiving the submission on April 7, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K931722 FDA.gov
FDA Decision	Cleared SEKD
Date Received	April 07, 1993
Decision Date	March 23, 1994
Days to Decision	350 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement

Device Classification

Product Code	MLS — Labor And Delivery Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.4530
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance