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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 K140865
Device Name INFRARED HEATING DEVICE
Applicant
Pro Medical Supplies, Inc.
Rm. 1706, # 128 Songle Rd.
Songjiang Area
Shanghai,  CN 201600
Applicant Contact DORIS DONG
Correspondent
Pro Medical Supplies, Inc.
Rm. 1706, # 128 Songle Rd.
Songjiang Area
Shanghai,  CN 201600
Correspondent Contact DORIS DONG
Regulation Number890.5500
Classification Product Code
ILY  
Date Received04/03/2014
Decision Date 09/03/2014
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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