Cleared Traditional

K863161 - TABLE, OPERATING ROOM, HYDRAULIC (FDA 510(k) Clearance)

Sep 1986
Decision
18d
Days
Class 1
Risk

K863161 is an FDA 510(k) clearance for the TABLE, OPERATING ROOM, HYDRAULIC. This device is classified as a Table, Operating-room, Pneumatic (Class I - General Controls, product code FWW).

Submitted by Kamiya Tsusan Kaisha, Ltd. (Japan, JP). The FDA issued a Cleared decision on September 5, 1986, 18 days after receiving the submission on August 18, 1986.

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

Submission Details

510(k) Number K863161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1986
Decision Date September 05, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FWW — Table, Operating-room, Pneumatic
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4960

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