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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K993332
Device Name GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
Applicant
Gradipore , Ltd.
Lot16 Riverside Corporate Park
35-105 Delhi Rd.
North Ryde,  AU NSW 2113
Applicant Contact RHONDA PILGRIM
Correspondent
Gradipore , Ltd.
Lot16 Riverside Corporate Park
35-105 Delhi Rd.
North Ryde,  AU NSW 2113
Correspondent Contact RHONDA PILGRIM
Regulation Number864.5425
Classification Product Code
GGC  
Date Received10/04/1999
Decision Date 02/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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