Cleared Traditional

K852332 - TABLE ACCESSORIES, OPERATING ROOM
(FDA 510(k) Clearance)

Jul 1985
Decision
32d
Days
Class 1
Risk

K852332 is an FDA 510(k) clearance for the TABLE ACCESSORIES, OPERATING ROOM. This device is classified as a Table And Attachments, Operating-room (Class I - General Controls, product code BWN).

Submitted by Scholten Surgical Instruments, Inc. (Redwood City, US). The FDA issued a Cleared decision on July 2, 1985, 32 days after receiving the submission on May 31, 1985.

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

Submission Details

510(k) Number K852332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date July 02, 1985
Days to Decision 32 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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