The following data is part of a premarket notification filed by The Lifestyle Company, Inc. with the FDA for Purilens Plus Preservative Free Saline.
Device ID | K200747 |
510k Number | K200747 |
Device Name: | PuriLens Plus Preservative Free Saline |
Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
Applicant | The LifeStyle Company, Inc. 6 Paragon Way Suite 112 Freehold, NJ 07728 |
Contact | Tom Seidner |
Correspondent | Michael A. Siano Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
Product Code | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & |
Subsequent Product Code | LPN |
Subsequent Product Code | MRC |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-23 |
Decision Date | 2020-05-15 |