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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microfilter, Blood Transfusion
510(k) Number K990310
Device Name CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
Applicant
Charter Medical, Ltd.
1805 Swarthmore Ave.
Lakewood,  NJ  08701
Applicant Contact DAVID HEAGLE
Correspondent
Charter Medical, Ltd.
1805 Swarthmore Ave.
Lakewood,  NJ  08701
Correspondent Contact DAVID HEAGLE
Regulation Number880.5440
Classification Product Code
CAK  
Date Received02/01/1999
Decision Date 08/30/1999
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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