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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K101322
Device Name JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001
Applicant
JOINSOON ELECTRONICS MFG CO LTD
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
JOINSOON ELECTRONICS MFG CO LTD
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/11/2010
Decision Date 07/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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