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FDA 510(k) Application Details - K211838
Device Classification Name
Instrument, Ultrasonic Surgical
More FDA Info for this Device
510(K) Number
K211838
Device Name
Instrument, Ultrasonic Surgical
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-cho
Hachioji-shi 192-8507 JP
Other 510(k) Applications for this Company
Contact
Toshiyuki Nakajima
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/14/2021
Decision Date
08/04/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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