Cleared Traditional

CPR C-SECTION DELIVERY PACK

K960243 · Custom Pack Reliability · Obstetrics & Gynecology
May 1996
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K960243 is an FDA 510(k) clearance for the CPR C-SECTION DELIVERY PACK, a Labor And Delivery Kit (Class II — Special Controls, product code MLS), submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on May 23, 1996, 128 days after receiving the submission on January 16, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K960243 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1996
Decision Date May 23, 1996
Days to Decision 128 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