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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K952435
Device Name CELSITE PEDIATRIC VENOUS SYSTEM
Applicant
B.Braun Medical, Inc.
Postfach 110 Carl Braun St. 1
D-3508
Melsungen,  DE
Applicant Contact MARK S ALSBBRGE
Correspondent
B.Braun Medical, Inc.
Postfach 110 Carl Braun St. 1
D-3508
Melsungen,  DE
Correspondent Contact MARK S ALSBBRGE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/24/1995
Decision Date 04/17/1996
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
Recalls CDRH Recalls
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