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FDA 510(k) Application Details - K140295
Device Classification Name
Gastroscope And Accessories, Flexible/Rigid
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510(K) Number
K140295
Device Name
Gastroscope And Accessories, Flexible/Rigid
Applicant
GI SCIENTIFIC LLC
128 Blye HIll Landing
Newbury, NH 03255 US
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Contact
MICHELE LUCEY
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Regulation Number
876.1500
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Classification Product Code
FDS
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More FDA Info for this Product Code
Date Received
02/06/2014
Decision Date
07/24/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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