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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 K082765
Device Name ASTOFLO PLUS
Applicant
Stihler Electronic GmbH
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact STEPHEN T MLCOCH
Correspondent
Stihler Electronic GmbH
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact STEPHEN T MLCOCH
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received09/22/2008
Decision Date 12/18/2008
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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