ALLEVYN ISLAND WOUND DRESSING— 510(k) K935705

Name: FDA 510(k) clearance K935705
Creator: U.S. Food and Drug Administration
Published: 1994-02-15

Substantially Equivalent

Smith & Nephew United, Inc.

FDA 510(k) clearance K935705 for ALLEVYN ISLAND WOUND DRESSING, Substantially Equivalent on 1994-02-15. Applicant: Smith & Nephew United, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew United, Inc.
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1993-11-30
Decision date: 1994-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NAE

view all

K083721 — MODIFICATION TO ZENIEVA2009-01-08
K082865 — MODIFICATION TO ZENIEVA2008-10-23
K073246 — ZENIEVA2008-07-23
K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING1999-09-17
K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING1999-06-28

More clearances from Smith & Nephew United, Inc.

view all

K963096 — ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING1996-10-25
K961775 — PROFORE FOUR-LAYER BANDAGE SYSTEM KIT1996-07-16
K945330 — ALLEVYN ADHESIVE1995-02-09
K943619 — CAVI-CARE CONFORMING FOAM DRESSING1994-08-19
K942748 — INTRASITE1994-06-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.