STELLAR

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 Stellar.

Pre-market Notification Details

• Device ID: K002463
• 510k Number: K002463
• Device Name: STELLAR
• Classification: Light, Surgical, Ceiling Mounted
• Applicant: SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST S.E. P.O.BOX 888615 Grand Rapids, MI 49588 -8615
• Contact: Kari Ogreen
• Correspondent: Kari Ogreen; SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST S.E. P.O.BOX 888615 Grand Rapids, MI 49588 -8615
• Product Code: FSY
• CFR Regulation Number: 878.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-08-10
• Decision Date: 2000-11-08