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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K790108
Device Name FILTERSET 0.22, I.V. PUMP
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 Number880.5440
Classification Product Code
FPA  
Date Received01/16/1979
Decision Date 03/06/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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