Cleared Traditional

K874494 - KAMBIN LAMINECTOMY FRAME
(FDA 510(k) Clearance)

K874494 · Avec Scientific Design Corp. · General & Plastic Surgery device

Nov 1987

Decision

21d

Days

Class 1

Risk

K874494 is an FDA 510(k) clearance for the KAMBIN LAMINECTOMY FRAME. This device is classified as a Surgical Table Cushion (Class I - General Controls, product code LWG).

Submitted by Avec Scientific Design Corp. (Philadelphia, US). The FDA issued a Cleared decision on November 23, 1987, 21 days after receiving the submission on November 2, 1987.

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

Submission Details

510(k) Number	K874494 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 02, 1987
Decision Date	November 23, 1987
Days to Decision	21 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—