Cleared Traditional

K943619 - CAVI-CARE CONFORMING FOAM DRESSING
(FDA 510(k) Clearance)

K943619 · Smith & Nephew United, Inc. · General & Plastic Surgery

Aug 1994

Decision

23d

Days

Class 1

Risk

K943619 is an FDA 510(k) clearance for the CAVI-CARE CONFORMING FOAM DRESSING. This device is classified as a Bandage, Liquid (Class I — General Controls, product code KMF).

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on August 19, 1994, 23 days after receiving the submission on July 27, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number	K943619 FDA.gov
FDA Decision	Cleared SN
Date Received	July 27, 1994
Decision Date	August 19, 1994
Days to Decision	23 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—