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FDA 510(k) Application Details - K221929
Device Classification Name
Endoscopic Central Control Unit
More FDA Info for this Device
510(K) Number
K221929
Device Name
Endoscopic Central Control Unit
Applicant
Smith+Nephew
150 Minuteman Road
Andover, MA 01810 US
Other 510(k) Applications for this Company
Contact
Kathleen Solomon
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODA
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More FDA Info for this Product Code
Date Received
07/01/2022
Decision Date
09/06/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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