Cleared Traditional

C-SECTION, LABOR & DELIVERY TRAYS (PACKS)

K932216 · Associated Medical Products Co. · Obstetrics & Gynecology
Apr 1994
Decision
347d
Days
Class 2
Risk

About This 510(k) Submission

K932216 is an FDA 510(k) clearance for the C-SECTION, LABOR & DELIVERY TRAYS (PACKS), a Labor And Delivery Kit (Class II — Special Controls, product code MLS), submitted by Associated Medical Products Co. (St. Louis Park, US). The FDA issued a Cleared decision on April 19, 1994, 347 days after receiving the submission on May 7, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K932216 FDA.gov
FDA Decision Cleared SESK
Date Received May 07, 1993
Decision Date April 19, 1994
Days to Decision 347 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