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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 K003538
Device Name TDP CQ-27 HEAT LAMP
Applicant
Lhasa Medical, Inc.
234 Libbey Pkwy.
Weymouth,  MA  02189
Applicant Contact KYUNG P RIIHIMAKI
Correspondent
Lhasa Medical, Inc.
234 Libbey Pkwy.
Weymouth,  MA  02189
Correspondent Contact KYUNG P RIIHIMAKI
Regulation Number890.5500
Classification Product Code
ILY  
Date Received11/16/2000
Decision Date 06/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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