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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Apparel With Material Claims
510(k) Number K180217
Device Name VESTEX Apparel
Applicant
Vestagen Protective Technologies, Inc.
1301 W. Colonial Dr.
Orlando,  FL  32804
Applicant Contact Scott Pease
Correspondent
Vestagen Protective Technologies, Inc.
1301 W. Colonial Dr.
Orlando,  FL  32804
Correspondent Contact Scott Pease
Regulation Number878.4040
Classification Product Code
QBW  
Date Received01/25/2018
Decision Date 05/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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