FDA 510(k) Application Details - K952660

Device Classification Name Catheter, Hemodialysis, Non-Implanted

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510(K) Number K952660
Device Name Catheter, Hemodialysis, Non-Implanted
Applicant B. BRAUN MEDICAL, INC.
805 GRANDVIEW DR.
SO. SAN FRANCISCO, CA 94080 US
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Contact MARK S ALSBERGE
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Regulation Number 876.5540

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Classification Product Code MPB
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Date Received 06/12/1995
Decision Date 09/17/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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