Cleared Traditional

K942553 - GENESIS
(FDA 510(k) Clearance)

K942553 · Burton Medical Products Corp. · General & Plastic Surgery device

Jun 1994

Decision

23d

Days

Class 2

Risk

K942553 is an FDA 510(k) clearance for the GENESIS. This device is classified as a Lamp, Surgical (Class II - Special Controls, product code FTD).

Submitted by Burton Medical Products Corp. (Chatsworth, US). The FDA issued a Cleared decision on June 23, 1994, 23 days after receiving the submission on May 31, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K942553 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 31, 1994
Decision Date	June 23, 1994
Days to Decision	23 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement