LACRIFAST

Lacrimal Stents And Intubation Sets

HIROYASU HIGUCHI

The following data is part of a premarket notification filed by Hiroyasu Higuchi with the FDA for Lacrifast.

Pre-market Notification Details

• Device ID: K120886
• 510k Number: K120886
• Device Name: LACRIFAST
• Classification: Lacrimal Stents And Intubation Sets
• Applicant: HIROYASU HIGUCHI 4-1 17 HONGO, BUNKYO-KU Tokyo, JP 113-0033
• Contact: Fumiaki Kanai, Ph.d.
• Correspondent: Fumiaki Kanai, Ph.d.; HIROYASU HIGUCHI 4-1 17 HONGO, BUNKYO-KU Tokyo, JP 113-0033
• Product Code: OKS
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-23
• Decision Date: 2012-12-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04540778140875	K120886	000
04540778140868	K120886	000