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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 K092222
Device Name THERMAPULSE
Applicant
Palomar Medical Products, Inc.
82 Cambridge St.
Burlington,  MA  01803
Applicant Contact Sharon Timberlake
Correspondent
Palomar Medical Products, Inc.
82 Cambridge St.
Burlington,  MA  01803
Correspondent Contact Sharon Timberlake
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/23/2009
Decision Date 08/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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