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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 K954331
Device Name PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
Applicant
Pall Biomedical Products Co.
2200 Northern Blvd.
East Hills,  NY  11548
Applicant Contact ROBERT A DICKSTEIN
Correspondent
Pall Biomedical Products Co.
2200 Northern Blvd.
East Hills,  NY  11548
Correspondent Contact ROBERT A DICKSTEIN
Regulation Number880.5440
Classification Product Code
FPB  
Date Received09/15/1995
Decision Date 01/09/1997
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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