Cleared Traditional

K882660 - GENERAL SURGICAL TABLE AND ACCESSORIES
(FDA 510(k) Clearance)

Jul 1988
Decision
27d
Days
Class 1
Risk

K882660 is an FDA 510(k) clearance for the GENERAL SURGICAL TABLE AND ACCESSORIES. 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 July 25, 1988, 27 days after receiving the submission on June 28, 1988.

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

Submission Details

510(k) Number K882660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1988
Decision Date July 25, 1988
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

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