Cleared Traditional

E-PACK PROCEDURE KITS

K951476 · Ethicon, Inc. · General & Plastic Surgery

May 1995

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K951476 is an FDA 510(k) clearance for the E-PACK PROCEDURE KITS, a Wound Dressing Kit (Class II — Special Controls, product code MCY), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 23, 1995, 54 days after receiving the submission on March 30, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number	K951476 FDA.gov
FDA Decision	Cleared SESK
Date Received	March 30, 1995
Decision Date	May 23, 1995
Days to Decision	54 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	MCY — Wound Dressing Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5075
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.