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FDA 510(k) Application Details - K200774
Device Classification Name
Instrument, Ultrasonic Surgical
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510(K) Number
K200774
Device Name
Instrument, Ultrasonic Surgical
Applicant
Integra LifeSciences Corporation
1100 Campus Rd
Princeton, NJ 08540 US
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Contact
Alexandra Wells
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Regulation Number
000.0000
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Classification Product Code
LFL
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More FDA Info for this Product Code
Date Received
03/25/2020
Decision Date
06/23/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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