Cleared Traditional

3M REMOVER LOTION PRODUCT NUMBER 86XX

K925618 · 3M Health Care, Ltd. · General & Plastic Surgery
Mar 1993
Decision
145d
Days
Class 1
Risk

About This 510(k) Submission

K925618 is an FDA 510(k) clearance for the 3M REMOVER LOTION PRODUCT NUMBER 86XX, a Solvent, Adhesive Tape (Class I — General Controls, product code KOX), submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on March 31, 1993, 145 days after receiving the submission on November 6, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4730.

Submission Details

510(k) Number K925618 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1992
Decision Date March 31, 1993
Days to Decision 145 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