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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K981509
Device Name TEMPO III
Applicant
Medical Products, Inc.
14014 Sullyfield Circle, #A
Chantilly,  VA  20151
Applicant Contact DURWARD FARIES, JR.
Correspondent
Medical Products, Inc.
14014 Sullyfield Circle, #A
Chantilly,  VA  20151
Correspondent Contact DURWARD FARIES, JR.
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received04/28/1998
Decision Date 07/10/1998
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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