The following data is part of a premarket notification filed by Vestagen Protective Technologies, Inc. with the FDA for Vestex Apparel.
Device ID | K180217 |
510k Number | K180217 |
Device Name: | VESTEX Apparel |
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 | Vestagen Protective Technologies, Inc. 1301 W. Colonial Dr. Orlando, FL 32804 |
Contact | Scott Pease |
Correspondent | Scott Pease Vestagen Protective Technologies, Inc. 1301 W. Colonial Dr. Orlando, FL 32804 |
Product Code | QBW |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-01-25 |
Decision Date | 2018-05-18 |
Summary: | summary |