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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K914589
Device Name SABRATEK 3030 INFUSION PUMP
Applicant
SABRATEK CORP.
1901 N. CLYBOURN AVE.
CHICAGO,  IL  60614
Applicant Contact SHAN PADDA
Correspondent
SABRATEK CORP.
1901 N. CLYBOURN AVE.
CHICAGO,  IL  60614
Correspondent Contact SHAN PADDA
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/16/1991
Decision Date 05/18/1992
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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