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FDA 510(k) Application Details - K091760
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K091760
Device Name
Catheter, Hemodialysis, Implanted
Applicant
DERMAPORT, INC
25102 RYE CANYON LOOP
SUITE 110
SANTA CLARITA, CA 91355 US
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Contact
JENNIFER HESSEL
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Regulation Number
876.5540
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Classification Product Code
MSD
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More FDA Info for this Product Code
Date Received
06/16/2009
Decision Date
07/20/2009
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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