LANDERS WIDE FIELD 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 Landers Wide Field Temporary Keratoprosthesis.

Pre-market Notification Details

• Device ID: K910828
• 510k Number: K910828
• Device Name: LANDERS WIDE FIELD 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: 1991-02-27
• Decision Date: 1991-08-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630238113168	K910828	000
00630238006897	K910828	000
00630238006880	K910828	000
00630238006873	K910828	000