ECKHARDT TEMPORARY KERATOPROSTHESIS

Keratoprosthesis, Temporary Implant, Surgical Use

DUTCH OPHTHALMIC USA, INC.

The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for Eckhardt Temporary Keratoprosthesis.

Pre-market Notification Details

• Device ID: K902491
• 510k Number: K902491
• Device Name: ECKHARDT TEMPORARY KERATOPROSTHESIS
• Classification: Keratoprosthesis, Temporary Implant, Surgical Use
• Applicant: DUTCH OPHTHALMIC USA, INC. TEN MARSHALL RD. P.O. BOX 968 Kingston, NH 03848
• Contact: Mark W Furlong
• Correspondent: Mark W Furlong; DUTCH OPHTHALMIC USA, INC. TEN MARSHALL RD. P.O. BOX 968 Kingston, NH 03848
• Product Code: MLP
• CFR Regulation Number: 886.3400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-06-05
• Decision Date: 1990-06-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08717872004570	K902491	000
08717872004549	K902491	000
08717872004532	K902491	000