Cleared Traditional

K971390 - QUANTUM 3080SP SURGICAL TABLE
(FDA 510(k) Clearance)

K971390 · STERIS Corporation · General & Plastic Surgery

May 1997

Decision

31d

Days

Class 1

Risk

K971390 is an FDA 510(k) clearance for the QUANTUM 3080SP SURGICAL TABLE, a Table, Operating-room, Electrical (Class I — General Controls, product code GDC), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 15, 1997, 31 days after receiving the submission on April 14, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K971390 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 1997
Decision Date	May 15, 1997
Days to Decision	31 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF