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FDA 510(k) Application Details - K211535
Device Classification Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
More FDA Info for this Device
510(K) Number
K211535
Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant
Gynesonics, Inc.
600 Chesapeake Drive
Redwood City, CA 94063 US
Other 510(k) Applications for this Company
Contact
Christine Ehmann
Other 510(k) Applications for this Contact
Regulation Number
884.4160
More FDA Info for this Regulation Number
Classification Product Code
KNF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/18/2021
Decision Date
06/17/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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