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FDA 510(k) Application Details - K171505
Device Classification Name
Needle, Fistula
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510(K) Number
K171505
Device Name
Needle, Fistula
Applicant
Dimesol, Inc.
509 Fishing Creek Road
Lewisberry, PA 17339 US
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Contact
Stephen P. Callaghan
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Regulation Number
876.5540
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Classification Product Code
FIE
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More FDA Info for this Product Code
Date Received
05/23/2017
Decision Date
05/17/2018
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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