Cleared Traditional

K862629 - SURGICAL LASER ACCESSORIES (SLA) CASE
(FDA 510(k) Clearance)

K862629 · Simpson/Basye, Inc. · General & Plastic Surgery

Jul 1986

Decision

Days

Class 1

Risk

K862629 is an FDA 510(k) clearance for the SURGICAL LASER ACCESSORIES (SLA) CASE. This device is classified as a Tray, Surgical, Instrument (Class I — General Controls, product code FSM).

Submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on July 17, 1986, 7 days after receiving the submission on July 10, 1986.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K862629 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 1986
Decision Date	July 17, 1986
Days to Decision	7 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—