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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K973103
Device Name CHARTERMED TPN-EVA BAGS
Applicant
Chartermed, Inc.
1805 Swarthmore Ave.
Lakewood,  NJ  08701
Applicant Contact K. ALICE PREVILLE
Correspondent
Chartermed, Inc.
1805 Swarthmore Ave.
Lakewood,  NJ  08701
Correspondent Contact K. ALICE PREVILLE
Regulation Number880.5025
Classification Product Code
KPE  
Date Received08/19/1997
Decision Date 11/24/1997
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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