LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET

Lens, Contact, Polymethylmethacrylate, Diagnostic

OCULAR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Landers High Refractive Index Vitrectomy Lens Set.

Pre-market Notification Details

• Device ID: K914117
• 510k Number: K914117
• Device Name: LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
• Classification: Lens, Contact, Polymethylmethacrylate, Diagnostic
• 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: HJK
• CFR Regulation Number: 886.1385 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-09-13
• Decision Date: 1991-11-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630238009959	K914117	000
00630238009942	K914117	000
00630238009935	K914117	000
00630238009928	K914117	000
00630238009911	K914117	000
00630238009904	K914117	000