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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 K040664
Device Name OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004
Applicant
Omnilight, Inc.
45 Dusty Trl. Dr.
Placitas,,  NM  87043
Applicant Contact RICK MURDOCK
Correspondent
Omnilight, Inc.
45 Dusty Trl. Dr.
Placitas,,  NM  87043
Correspondent Contact RICK MURDOCK
Regulation Number890.5500
Classification Product Code
ILY  
Date Received03/10/2004
Decision Date 05/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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