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FDA 510(k) Application Details - K172595
Device Classification Name
Instrument, Ultrasonic Surgical
More FDA Info for this Device
510(K) Number
K172595
Device Name
Instrument, Ultrasonic Surgical
Applicant
Integra LifeSciences Corporation
311 Enterprise Drive
PLAINSBORO, NJ 08536 US
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Contact
Alexandra Wells
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
08/29/2017
Decision Date
09/28/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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