Cleared Traditional

AMSCO SURGICAL TABLE

K971307 · STERIS Corporation · General & Plastic Surgery
Jun 1997
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K971307 is an FDA 510(k) clearance for the AMSCO SURGICAL TABLE, a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on June 27, 1997, 80 days after receiving the submission on April 8, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K971307 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1997
Decision Date June 27, 1997
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FQO — Table, Operating-room, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960

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