COBO TEMPORARY KERATOPROSTHESIS

Keratoprosthesis, Temporary Implant, Surgical Use

OCULAR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Cobo Temporary Keratoprosthesis.

Pre-market Notification Details

• Device ID: K895013
• 510k Number: K895013
• Device Name: COBO TEMPORARY KERATOPROSTHESIS
• Classification: Keratoprosthesis, Temporary Implant, Surgical Use
• Applicant: OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039
• Contact: Tamsin J Erickson
• Correspondent: Tamsin J Erickson; OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039
• Product Code: MLP
• CFR Regulation Number: 886.3400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-08-08
• Decision Date: 1989-10-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630238008938	K895013	000
00630238008921	K895013	000
00630238008914	K895013	000