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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K844227
Device Name INFUSART
Applicant
Sartorius, Inc.
Postfach 3243
D-3400
Gottingen, Germany,  DE
Correspondent
Sartorius, Inc.
Postfach 3243
D-3400
Gottingen, Germany,  DE
Regulation Number880.2420
Classification Product Code
FLN  
Date Received11/01/1984
Decision Date 01/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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