Cleared Traditional

K915150 - REMOVE ADHESIVE REMOVER
(FDA 510(k) Clearance)

K915150 · Smith & Nephew United, Inc. · General & Plastic Surgery
Jan 1992
Decision
56d
Days
Class 1
Risk

K915150 is an FDA 510(k) clearance for the REMOVE ADHESIVE REMOVER, a Solvent, Adhesive Tape (Class I — General Controls, product code KOX), submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on January 9, 1992, 56 days after receiving the submission on November 14, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4730.

Submission Details

510(k) Number K915150 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1991
Decision Date January 09, 1992
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code KOX — Solvent, Adhesive Tape
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4730