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FDA 510(k) Application Details - K001958
Device Classification Name
Catheter, Hemodialysis, Non-Implanted
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510(K) Number
K001958
Device Name
Catheter, Hemodialysis, Non-Implanted
Applicant
KEYSTONE MEDICAL
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
ALAN P SCHWARTZ
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Regulation Number
876.5540
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Classification Product Code
MPB
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More FDA Info for this Product Code
Date Received
06/27/2000
Decision Date
09/25/2000
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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