Cleared Traditional

PRESSURE SORE MANAGEMENT KIT

K912116 · Medical Device Inspection Co., Inc. · General & Plastic Surgery

Oct 1991

Decision

157d

Days

Class 2

Risk

About This 510(k) Submission

K912116 is an FDA 510(k) clearance for the PRESSURE SORE MANAGEMENT KIT, a Wound Dressing Kit (Class II — Special Controls, product code MCY), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on October 18, 1991, 157 days after receiving the submission on May 14, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number	K912116 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 1991
Decision Date	October 18, 1991
Days to Decision	157 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

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.