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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 K912192
Device Name 3100 INFUSION PUMP
Applicant
Graseby Medical , Ltd.
Colonial Way
Watford, Herts.,  GB WD24 4LG
Applicant Contact DERLIEN
Correspondent
Graseby Medical , Ltd.
Colonial Way
Watford, Herts.,  GB WD24 4LG
Correspondent Contact DERLIEN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/17/1991
Decision Date 02/14/1992
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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