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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 K973748
Device Name TEMPO AND TEMP H20
Applicant
SMITH
P.O. BOX 4341
CROFTON,  MD  21114
Applicant Contact DURWARD FARIES, JR.
Correspondent
SMITH
P.O. BOX 4341
CROFTON,  MD  21114
Correspondent Contact DURWARD FARIES, JR.
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received10/01/1997
Decision Date 03/10/1998
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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