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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Blood Transfusion
510(k) Number K000685
Device Name CHARTER MEDICAL NEONATAL SYRINGE SET
Applicant
Charter Medical, Ltd.
1805 Swarthmore Ave.
Lakewood,  NJ  08701
Applicant Contact K. ALICE PREVILLE
Correspondent
Charter Medical, Ltd.
1805 Swarthmore Ave.
Lakewood,  NJ  08701
Correspondent Contact K. ALICE PREVILLE
Regulation Number880.5440
Classification Product Code
BRZ  
Subsequent Product Code
FMF  
Date Received02/29/2000
Decision Date 08/15/2000
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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