Cleared Traditional

OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY

K971061 · Opportunity, Inc. · General & Plastic Surgery

Jun 1997

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K971061 is an FDA 510(k) clearance for the OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY, a General Surgery Tray (Class II — Special Controls, product code LRO), submitted by Opportunity, Inc. (Highland Park, US). The FDA issued a Cleared decision on June 11, 1997, 79 days after receiving the submission on March 24, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K971061 FDA.gov
FDA Decision	Cleared SN
Date Received	March 24, 1997
Decision Date	June 11, 1997
Days to Decision	79 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

Device Classification

Product Code	LRO — General Surgery Tray
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4370
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance