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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 K781171
Device Name INFUSION PUMP, PEDIATRIC MODEL 301
Applicant
IMED CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IMED CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/13/1978
Decision Date 08/10/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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