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FDA 510(k) Application Details - K991431
Device Classification Name
Catheter, Hemodialysis, Non-Implanted
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510(K) Number
K991431
Device Name
Catheter, Hemodialysis, Non-Implanted
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING, PA 19605 US
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Contact
THOMAS D NICKEL
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Regulation Number
876.5540
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Classification Product Code
MPB
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Date Received
04/26/1999
Decision Date
05/26/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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