Cleared Traditional

K930493 - QUANTUM 3080 SURGICAL TABLE
(FDA 510(k) Clearance)

K930493 · American Sterilizer Co. · General & Plastic Surgery device

Jun 1993

Decision

141d

Days

Class 1

Risk

K930493 is an FDA 510(k) clearance for the QUANTUM 3080 SURGICAL TABLE. This device is classified as a Table, Operating-room, Ac-powered (Class I - General Controls, product code FQO).

Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on June 22, 1993, 141 days after receiving the submission on February 1, 1993.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K930493 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 01, 1993
Decision Date	June 22, 1993
Days to Decision	141 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF