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FDA 510(k) Application Details - K192498
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
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510(K) Number
K192498
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-machi
Hachioji-shi 192-8507 JP
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Contact
Toshiyuki Nakajima
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Regulation Number
876.1500
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Classification Product Code
FBK
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More FDA Info for this Product Code
Date Received
09/11/2019
Decision Date
04/28/2020
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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