Cleared Traditional

K942748 - INTRASITE
(FDA 510(k) Clearance)

K942748 · Smith & Nephew United, Inc. · General & Plastic Surgery

Jun 1994

Decision

19d

Days

Class 1

Risk

K942748 is an FDA 510(k) clearance for the INTRASITE. This device is classified as a Dressing, Wound, Hydrogel Without Drug And/or Biologic (Class I — General Controls, product code NAE).

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on June 29, 1994, 19 days after receiving the submission on June 10, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4022.

Submission Details

510(k) Number	K942748 FDA.gov
FDA Decision	Cleared SN
Date Received	June 10, 1994
Decision Date	June 29, 1994
Days to Decision	19 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—