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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K842399
Device Name 48 HOUR SET CHANGES
Applicant
Tri-Med, Inc.
5842 Research Dr.
Huntington Beach,  CA  92649
Applicant Contact ARDEN P MORLEY
Correspondent
Tri-Med, Inc.
5842 Research Dr.
Huntington Beach,  CA  92649
Correspondent Contact ARDEN P MORLEY
Regulation Number880.5440
Classification Product Code
FPB  
Date Received06/19/1984
Decision Date 10/09/1984
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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