Cleared Traditional

LACERATION TRAY

K912117 · Medical Device Inspection Co., Inc. · General & Plastic Surgery

Aug 1991

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K912117 is an FDA 510(k) clearance for the LACERATION TRAY, 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 August 9, 1991, 88 days after receiving the submission on May 13, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number	K912117 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 1991
Decision Date	August 09, 1991
Days to Decision	88 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.