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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name i.v. start kit
510(k) Number K950184
Device Name B. BRAUN IV START KITS
Applicant
B. BRAUN OF AMERICA, INC.
824 TWELFTH AVE.
PO BOX 4027
BETHLEHEM,  PA  18018 -0027
Applicant Contact MARK S ALSBERGE
Correspondent
B. BRAUN OF AMERICA, INC.
824 TWELFTH AVE.
PO BOX 4027
BETHLEHEM,  PA  18018 -0027
Correspondent Contact MARK S ALSBERGE
Regulation Number880.5200
Classification Product Code
LRS  
Date Received01/17/1995
Decision Date 03/15/1995
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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