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FDA 510(k) Application Details - K141058
Device Classification Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
More FDA Info for this Device
510(K) Number
K141058
Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant
SLATER ENDOSCOPY, LLC
1135 W NASA BLVD. SUITE 500
MELBOURNE, FL 32901 US
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Contact
CRAIG PAGAN
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
OCZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/24/2014
Decision Date
08/01/2014
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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