GENIE

Light, Surgical, Ceiling Mounted

BURTON MEDICAL PRODUCTS CORP.

The following data is part of a premarket notification filed by Burton Medical Products Corp. with the FDA for Genie.

Pre-market Notification Details

• Device ID: K961843
• 510k Number: K961843
• Device Name: GENIE
• Classification: Light, Surgical, Ceiling Mounted
• Applicant: BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311
• Contact: Gretel Lumley
• Correspondent: Gretel Lumley; BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311
• Product Code: FSY
• CFR Regulation Number: 878.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-13
• Decision Date: 1996-08-22