FDA 510(k) Application Details - K221763

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K221763
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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Date Received 06/17/2022
Decision Date 07/15/2022
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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