Cleared Traditional

K902865 - BAUMER SURGICAL TABLE
(FDA 510(k) Clearance)

Sep 1990
Decision
73d
Days
Class 1
Risk

K902865 is an FDA 510(k) clearance for the BAUMER SURGICAL TABLE. This device is classified as a Table And Attachments, Operating-room (Class I - General Controls, product code BWN).

Submitted by Sds Dental, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on September 10, 1990, 73 days after receiving the submission on June 29, 1990.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K902865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1990
Decision Date September 10, 1990
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code BWN — Table And Attachments, Operating-room
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4950

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