Cleared Traditional

K932602 - ADHESIVE BANDAGES
(FDA 510(k) Clearance)

Aug 1993
Decision
73d
Days
Class 1
Risk

K932602 is an FDA 510(k) clearance for the ADHESIVE BANDAGES. This device is classified as a Tape And Bandage, Adhesive (Class I - General Controls, product code KGX).

Submitted by Aso Corp. (Sarasota, US). The FDA issued a Cleared decision on August 9, 1993, 73 days after receiving the submission on May 28, 1993.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number K932602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1993
Decision Date August 09, 1993
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGX — Tape And Bandage, Adhesive
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.5240

Similar Devices — KGX Tape And Bandage, Adhesive

All 186
SERAGARD INJECTION PATCH
K001240 · Platinum Services, Inc. · Jun 2000
CARE BAND ANTIBACTERIAL BANDAGES
K983368 · Aso Corp. · Feb 1999
SYVEK PATCH
K972914 · Marine Polymer Technologies, Inc. · Dec 1997
ADHESIVE BANDAGES WITH OTC DRUG
K943314 · Johnson & Johnson Consumer Products, Inc. · Jan 1996
TARGETT PATCH
K952606 · Cutting Edge Technologies, Inc. · Dec 1995
PARALLEL
K954007 · Johnson & Johnson Consumer Products, Inc. · Nov 1995