Universal Light Handle Cover, Light Handle Cover

Light, Surgical, Accessories

Key Surgical, Inc.

The following data is part of a premarket notification filed by Key Surgical, Inc. with the FDA for Universal Light Handle Cover, Light Handle Cover.

Pre-market Notification Details

• Device ID: K150532
• 510k Number: K150532
• Device Name: Universal Light Handle Cover, Light Handle Cover
• Classification: Light, Surgical, Accessories
• Applicant: Key Surgical, Inc. 8101 Wallace Road Eden Prairie, MN 55344
• Contact: Amy Yanta
• Correspondent: Amy Yanta; Key Surgical, Inc. 8101 Wallace Road Eden Prairie, MN 55344
• Product Code: FTA
• CFR Regulation Number: 878.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-03-02
• Decision Date: 2015-09-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10849771030628	K150532	000
10849771030611	K150532	000
10849771030604	K150532	000
10849771030598	K150532	000