Cleared Traditional

DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM

K970721 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery

Mar 1997

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K970721 is an FDA 510(k) clearance for the DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM, a Wound Dressing Kit (Class II — Special Controls, product code MCY), submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on March 21, 1997, 22 days after receiving the submission on February 27, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number	K970721 FDA.gov
FDA Decision	Cleared SN
Date Received	February 27, 1997
Decision Date	March 21, 1997
Days to Decision	22 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

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.