Cleared Traditional

K971088 - OPPORTUNITY INCISION AND DRAINAGE TRAY
(FDA 510(k) Clearance)

K971088 · Opportunity, Inc. · General & Plastic Surgery

Sep 1997

Decision

176d

Days

—

Risk

K971088 is an FDA 510(k) clearance for the OPPORTUNITY INCISION AND DRAINAGE TRAY. This device is classified as a Gauze/sponge, Internal.

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 FDA review panel.

Submission Details

510(k) Number	K971088 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	—