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FDA 510(k) Application Details - K150682
Device Classification Name
Instrument, Ultrasonic Surgical
More FDA Info for this Device
510(K) Number
K150682
Device Name
Instrument, Ultrasonic Surgical
Applicant
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
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Contact
JENNIFER SIEGEL
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFL
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More FDA Info for this Product Code
Date Received
03/17/2015
Decision Date
12/18/2015
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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