Cleared Traditional

K952334 - DRESSING CHANGE TRAY
(FDA 510(k) Clearance)

K952334 · Busse Hospital Disposables, Inc. · General & Plastic Surgery

Jul 1995

Decision

57d

Days

Class 2

Risk

K952334 is an FDA 510(k) clearance for the DRESSING CHANGE TRAY. This device is classified as a Wound Dressing Kit (Class II — Special Controls, product code MCY).

Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on July 14, 1995, 57 days after receiving the submission on May 18, 1995.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5075. 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..

Submission Details

510(k) Number	K952334 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1995
Decision Date	July 14, 1995
Days to Decision	57 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.