FDA 510(k) Application Details - K150682

Device Classification Name Instrument, Ultrasonic Surgical

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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
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Regulation Number 000.0000

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Classification Product Code LFL
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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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