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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K041222
Device Name PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
Applicant
B. Braun Medical, Inc.
1601 Wallace Dr., Suite 150
Carrollton,  TX  75006
Applicant Contact LINDA MORGAN
Correspondent
B. Braun Medical, Inc.
1601 Wallace Dr., Suite 150
Carrollton,  TX  75006
Correspondent Contact LINDA MORGAN
Regulation Number880.5440
Classification Product Code
LHI  
Date Received05/10/2004
Decision Date 10/14/2004
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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