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FDA 510(k) Application Details - K193424
Device Classification Name
More FDA Info for this Device
510(K) Number
K193424
Device Name
Resolution 360Ö ULTRA Clip
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
Other 510(k) Applications for this Company
Contact
Elena Hennessey
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
12/10/2019
Decision Date
09/01/2020
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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