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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 K941984
Device Name SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP
Applicant
Sabratek Corp.
1046 W. Willow St.
Chicago,  IL  60614
Applicant Contact CHARLES P GILL
Correspondent
Sabratek Corp.
1046 W. Willow St.
Chicago,  IL  60614
Correspondent Contact CHARLES P GILL
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/25/1994
Decision Date 07/19/1994
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
Recalls CDRH Recalls
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