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FDA 510(k) Application Details - K181084
Device Classification Name
Colonoscope And Accessories, Flexible/Rigid
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510(K) Number
K181084
Device Name
Colonoscope And Accessories, Flexible/Rigid
Applicant
PENTAX of America, Inc.
3 Paragon Drive
Montvale, NJ 07645-1782 US
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Contact
James W. Monroe
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Regulation Number
876.1500
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Classification Product Code
FDF
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More FDA Info for this Product Code
Date Received
04/24/2018
Decision Date
01/18/2019
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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