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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 K033082
Device Name 9 SECOND DIGITAL THERMOMETER, MODEL BT-S09
Applicant
Metatech Co., Ltd.
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Applicant Contact GUENTER GINSBERG
Correspondent
Metatech Co., Ltd.
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/29/2003
Decision Date 12/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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