FDA 510(k) Application Details - K952548

Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular

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510(K) Number K952548
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM, PA US
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Contact MARK S ALSBERGE
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 06/02/1995
Decision Date 07/21/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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