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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K162763
Device Name Vevazz LED Heat Lamp
Applicant
Vevazz, LLC
30520 Rancho California Rd., Suite 107-46
Temecula,  CA  92591
Applicant Contact Jamie Fettig
Correspondent
Vevazz, LLC
30520 Rancho California Rd., Suite 107-46
Temecula,  CA  92591
Correspondent Contact Jamie Fettig
Regulation Number890.5500
Classification Product Code
ILY  
Date Received09/30/2016
Decision Date 01/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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