Cleared Traditional

K943871 - AQUAPLAST TIE DOWN DRESSING
(FDA 510(k) Clearance)

K943871 · Wfr/Aquaplast Corp. · General & Plastic Surgery
Sep 1994
Decision
53d
Days
Class 1
Risk

K943871 is an FDA 510(k) clearance for the AQUAPLAST TIE DOWN DRESSING. This device is classified as a Guard, Skin Graft (Class I — General Controls, product code LZM).

Submitted by Wfr/Aquaplast Corp. (Wyckoff, US). The FDA issued a Cleared decision on September 30, 1994, 53 days after receiving the submission on August 8, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4014.

Submission Details

510(k) Number K943871 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1994
Decision Date September 30, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code LZM — Guard, Skin Graft
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4014