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FDA 510(k) Application Details - K142397
Device Classification Name
Endoscopic Guidewire, Gastroenterology-Urology
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510(K) Number
K142397
Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Applicant
Lake Region Medical
340 Lake Hazeltine Dr.
Chaska, MN 55318 US
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Contact
Mathew Pexa
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Regulation Number
876.1500
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Classification Product Code
OCY
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More FDA Info for this Product Code
Date Received
08/27/2014
Decision Date
09/19/2014
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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