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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 K093204
Device Name INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM
Applicant
Innovative Med, Inc.
4 Autry, Unit B
Irvine,  CA  92618
Applicant Contact JEFFREY KOLSTER
Correspondent
Innovative Med, Inc.
4 Autry, Unit B
Irvine,  CA  92618
Correspondent Contact JEFFREY KOLSTER
Regulation Number890.5500
Classification Product Code
ILY  
Date Received10/13/2009
Decision Date 08/23/2010
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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