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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
Models WARP-10A, WARP-75A
Device Name WARP10,WARP75
Original Applicant
QUANTUM DEVICES, INC.
1920 arlington pl.
medison,  WI  53726
Original Contact morris waxler
Regulation Number890.5500
Classification Product Code
ILY  
Date Received11/02/2011
Decision Date 02/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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