Cleared Traditional

K971089 - OPPORTUNITY, INC. LACERATION TRAY
(FDA 510(k) Clearance)

K971089 · Opportunity, Inc. · General Hospital

Sep 1997

Decision

176d

Days

Class 2

Risk

K971089 is an FDA 510(k) clearance for the OPPORTUNITY, INC. LACERATION TRAY, a Drape, Surgical (Class II — Special Controls, product code KKX), 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 Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K971089 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 Hospital (HO)
Summary	—