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FDA 510(k) Application Details - K013889
Device Classification Name
More FDA Info for this Device
510(K) Number
K013889
Device Name
ENDOSCOPIC MULTI-FIRE CLIP APPLIER
Applicant
INSCOPE, LLC.
8210 NW 27TH ST.
MIAMI, FL 33122 US
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Contact
BRUCE WEBER
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PKL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/23/2001
Decision Date
02/07/2002
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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