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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 K012276
Device Name TEMP 3
Applicant
Medical Solutions, Inc.
3901 Centerview Dr., Suite W
Chantilly,  VA  20151
Applicant Contact BRUCE HEYMANN
Correspondent
Medical Solutions, Inc.
3901 Centerview Dr., Suite W
Chantilly,  VA  20151
Correspondent Contact BRUCE HEYMANN
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received07/19/2001
Decision Date 08/20/2001
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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