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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K051699
Device Name SEJOY, MODEL MT-403
Applicant
Sejoy Electronics & Instruments Co., Ltd.
1255 San Tomas Aquino Rd. #214
San Jose,  CA  95117
Applicant Contact JIANYAO WU
Correspondent
Sejoy Electronics & Instruments Co., Ltd.
1255 San Tomas Aquino Rd. #214
San Jose,  CA  95117
Correspondent Contact JIANYAO WU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/24/2005
Decision Date 02/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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