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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 K032714
Device Name CARDICARE MODEL MT-301F & MT-301C
Applicant
Lumiscope Co., Inc.
122 Tices Ln.
East Brunswick,  NJ  08816
Applicant Contact MARIO MANZANO
Correspondent
Lumiscope Co., Inc.
122 Tices Ln.
East Brunswick,  NJ  08816
Correspondent Contact MARIO MANZANO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/02/2003
Decision Date 10/22/2003
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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