Cleared Traditional

K971091 - OPPURTUNITY TRACHEOSTOMY CARE KIT
(FDA 510(k) Clearance)

K971091 · Opportunity, Inc. · General & Plastic Surgery

Sep 1997

Decision

176d

Days

Class 1

Risk

K971091 is an FDA 510(k) clearance for the OPPURTUNITY TRACHEOSTOMY CARE KIT, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Opportunity, Inc. (Highland Park, US). The FDA issued a Cleared decision on September 16, 1997, 176 days after receiving the submission on March 24, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number	K971091 FDA.gov
FDA Decision	Cleared SN
Date Received	March 24, 1997
Decision Date	September 16, 1997
Days to Decision	176 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—