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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 K030385
Device Name IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
Applicant
Kawasumi Laboratories America, Inc.
5905 C Hampton Oaks Pkwy.
Tampa,  FL  33610
Applicant Contact JACK PAVLO
Correspondent
Kawasumi Laboratories America, Inc.
5905 C Hampton Oaks Pkwy.
Tampa,  FL  33610
Correspondent Contact JACK PAVLO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/05/2003
Decision Date 04/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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