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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 K113231
Device Name WARP10,WARP75
Applicant
Quantum Devices, Inc.
1920 Arlington Pl.
Madison,  WI  53726
Applicant Contact MORRIS WAXLER
Correspondent
Quantum Devices, Inc.
1920 Arlington Pl.
Madison,  WI  53726
Correspondent Contact MORRIS WAXLER
Regulation Number890.5500
Classification Product Code
ILY  
Date Received11/02/2011
Decision Date 02/27/2012
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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