MILLENNIUM GOLD

Light, Surgical, Ceiling Mounted

SKYTRON, DIV. THE KMW GROUP, INC.

The following data is part of a premarket notification filed by Skytron, Div. The Kmw Group, Inc. with the FDA for Millennium Gold.

Pre-market Notification Details

• Device ID: K992090
• 510k Number: K992090
• Device Name: MILLENNIUM GOLD
• Classification: Light, Surgical, Ceiling Mounted
• Applicant: SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST., S.E. Grand Rapids, MI 49512
• Contact: Kari Ogreen
• Correspondent: Kari Ogreen; SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST., S.E. Grand Rapids, MI 49512
• Product Code: FSY
• CFR Regulation Number: 878.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-21
• Decision Date: 1999-09-08