Lubricity

Saliva, Artificial

You First Services, Incorporated

The following data is part of a premarket notification filed by You First Services, Incorporated with the FDA for Lubricity.

Pre-market Notification Details

• Device ID: K163476
• 510k Number: K163476
• Device Name: Lubricity
• Classification: Saliva, Artificial
• Applicant: You First Services, Incorporated 1576 Sweet Home Road Amherst, NY 14228
• Contact: Jeffrey Eberhard
• Correspondent: Jeffrey Eberhard; You First Services, Incorporated 1576 Sweet Home Road Amherst, NY 14228
• Product Code: LFD
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-12
• Decision Date: 2017-05-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00864206000123	K163476	000
00864206000109	K163476	000