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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 STR 1
D-3508
MELSUNGEN,  DE
Applicant Contact MARK S ALSBBRGE
Correspondent
B. BRAUN MEDICAL, INC.
POSTFACH 110 CARL BRAUN STR 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
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