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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K852882
Device Name MAXIFILL TRANSFER SET
Applicant
Lyphomed, Inc.
2045 N. Cornell Ave.
Melrose Park,  IL  60160
Applicant Contact DIANE M KOMOS
Correspondent
Lyphomed, Inc.
2045 N. Cornell Ave.
Melrose Park,  IL  60160
Correspondent Contact DIANE M KOMOS
Regulation Number880.5440
Classification Product Code
LHI  
Date Received07/09/1985
Decision Date 08/16/1985
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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