ENDOBEAM

Light Source, Endoscope, Xenon Arc

CORIN U.S.A.

The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Endobeam.

Pre-market Notification Details

• Device ID: K963044
• 510k Number: K963044
• Device Name: ENDOBEAM
• Classification: Light Source, Endoscope, Xenon Arc
• Applicant: CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612
• Contact: Jack Thomas
• Correspondent: Jack Thomas; CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612
• Product Code: GCT
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-08-05
• Decision Date: 1996-09-20
• Summary: summary